Devices for minimally invasive pelvic surgery

ABSTRACT

Devices and methods relating to percutaneous and hiatal approaches for treating urinary incontinence are provided herein. In particular, guide member placement devices, sling application catheters, tissue dissectors/dilators, sling application devices and a sling application system, tissue expanders, grasping devices, and balloon catheters are disclosed herein. Methods for using the preceding devices to stabilize the bladder neck or the urethral floor in order to maintain or improve urinary incontinence are also disclosed.

RELATED APPLICATIONS

[0001] This application claims priority from U.S. Provisional PatentApplication Serial No. 60/038,171, filed Feb. 13, 1997.

FIELD OF THE INVENTION

[0002] The present invention relates to devices and methods for treatingincontinence.

BACKGROUND OF THE INVENTION

[0003] Urinary incontinence is a widespread problem in the United Statesand throughout the world. Urinary incontinence affects people of allages and can severely impact a patient both physiologically andpsychologically.

[0004] In approximately 30% of the women suffering from urinaryincontinence, incontinence is caused by intrinsic sphincter deficiency(ISD), a condition in which the valves of the urethral sphincter do notproperly coapt. In approximately another 30% of incontinent women,incontinence is caused by hypermobility, a condition in which themuscles around the bladder relax, causing the bladder neck and proximalurethra to rotate and descend in response to increases in intraabdominalpressure. Hypermobility may be the result of pregnancy or otherconditions which weaken the muscles. In an additional group of womenwith urinary incontinence, the condition is caused by a combination ofISD and hypermobility.

[0005] In addition to the conditions described above, urinaryincontinence has a number of other causes, including birth defects,disease, injury, aging, and urinary tract infection.

[0006] Numerous approaches for treating urinary incontinence areavailable. For example, several procedures for stabilizing and/orslightly compressing the urethra so as to prevent the leakage of urinehave been developed. The stabilizing or compressive force may be applieddirectly by sutures passing through the soft tissue surrounding theurethra or, alternatively, may be applied by means of a sling locatedunder the urethra and suspended by sutures. The sutures may be anchoredto the pubic bone by means of bone anchors or, alternatively, thesutures may be attached to other structures such as fascia.

[0007] A device for dissecting around a tubular structure such as theurethra or the bladder neck is available from Lone Star MedicalProducts. The Lone Star device has two shafts which can be positioned inthe tissue between the urethra and the vaginal wall using cystoscopy,vaginal or rectal examination, or an examination of the position of theinstrument around the urethra with the bladder opened. The two shaftscan be locked together to pinch the intervening tissue. A sharp blade isinserted into one of the shafts and advanced into the second shaft,cutting the tissue in between the two shafts. The cut in the tissue canbe expanded using a right angle clamp and an artificial sphincter guidedby a suture attached to the cutting blade of the device can beintroduced into the expanded cut.

[0008] With the Lone Star device, the distance between the two shaftscannot be gradually adjusted. In addition, the ends of the shafts of theLone Star device come in direct contact with the tissue or bone whilebeing advanced towards the tissue between the urethra and the uppervaginal wall. The shafts of the Lone Star device are flat at theirdistal ends.

[0009] Thus, there is a need for devices which simplify treatments forurinary incontinence and increase their safety. Sling applicationdevices for treating urinary incontinence which reduce the risk ofinadvertent pinching of the urethra and undesirable scoring of tissue orbone during advancement of the device would be particularly desirable.It is also desirable to have a sling application device that does notemploy a guiding suture and can create or maintain an opening in thetissue between the urethra and the upper vaginal wall without the use ofa right angle clamp, thereby simplifying the procedure.

[0010] U.S. Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev et al.,introduces pioneering minimally invasive percutaneous and transvaginalbladder neck stabilization approaches. The percutaneous approach ofBenderev et al. involves stabilizing the bladder neck using a boneanchor which is percutaneously introduced from the abdominal side of thepatient. The transvaginal approach of Benderev et al. involvesstabilizing the bladder neck using a staple or bone anchor which istransvaginally placed into the pubic bone. There is also a need forfurther devices and methods for improving or maintaining urinarycontinence involving stabilization or compression of the bladder neck orurethra, particularly devices and methods of the present invention thatare less invasive than many of those currently available.

SUMMARY OF THE INVENTION

[0011] The present invention relates to devices and methods for use inpercutaneous and hiatal approaches treatments for urinary incontinence.In particular, the present invention relates to guide member placementdevices, sling application catheters, tissue dissectors/dilators, slingapplication devices and a sling application system, tissue expanders,grasping devices, and balloon catheters. Methods for using the precedingdevices to stabilize the bladder neck or the urethral floor in order tomaintain or improve urinary continence are also disclosed.

[0012] One aspect of the present invention is a guide member placementdevice for inserting a guide member in a body tissue. The guide memberplacement device comprises a shaft having a proximal end, a distal end,and a lumen extending therethrough. The lumen of the shaft is adaptedfor receiving a guidemember. The distal end of the shaft has an engagingmember for engaging another guide member placement device. In oneembodiment of the guide member placement device, the device furthercomprises a blunt dissection tip at the distal end of the shaft and ahandle with a lumen extending therethrough wherein the lumen of theshaft and the lumen of the handle are aligned. In a further embodiment,the blunt dissection tip is on a blunt dissector within the shaft and isextendable from and retractable in the shaft. In a further embodiment,the guide member placement device is adapted for use in urethral floorreconstruction procedures. In yet another embodiment, the guide memberplacement device is adapted for use in bladder neck stabilizationprocedures. In one embodiment of the guide member placement device, theengaging member comprises a male connector. In another embodiment of theguide member placement device, the engaging member comprises a femaleconnector. In yet another embodiment of the guidemember placementdevice, the shaft has a straight proximal section, a bent intermediatesection and a distal end oriented at an angle of approximately 90degrees relative to the proximal section. In another embodiment, theguide member placement device further comprises a guide member removablypositioned in the lumen of the shaft. In one aspect of this embodiment,the guide member comprises a guide wire. In another aspect of thisembodiment, the guide member comprises a suture.

[0013] Another aspect of the present invention is a method of insertinga guide member into a body tissue. A shaft of a first guide memberplacement device is inserted percutaneously and advanced through thebody tissue to a central point through which the guide member will pass.A shaft of a second guide member placement device is insertedpercutaneously and advanced through the body tissue to the central pointthrough which the guide member will pass. An engaging member on a distalend of the shaft of the first guide member placement device is coupledto an engaging member on a distal end of a shaft of a second guidemember placement device such that a lumen in the shaft of the firstguide member placement device is fluid communication with a lumen in theshaft of the second guide member placement device. A guide member ispassed through the lumens of the coupled shafts of the first guidemember placement device and the second guide member placement device.The shaft of the first guide member placement device and the shaft ofthe second guide member placement device are removed from the body,thereby leaving the guide member in the body tissue. In one embodimentof the method, the first and second shafts are percutaneously insertedthrough first and second suprapubic incisions. In another embodiment ofthe method, the shafts of the first and second guide member placementdevices are inserted into a pre-formed opening or pocket in the bodytissue. In another embodiment of the method, the method furthercomprises the step of creating an opening in the body tissue byextending and retracting a blunt dissector tip from at least one of theguide member placement devices. In another embodiment of the method, thepre-formed opening or pocket is in the tissue between the urethra andthe upper vaginal wall such that the guide member is left in thepre-formed opening or pocket.

[0014] Another aspect of the present invention is a sling applicationcatheter comprising a catheter having a sling therein, wherein the slingis releasably engaged with the catheter. In one embodiment of the slingapplication catheter, the catheter has a pouch therein for releasablyengaging the sling. The sling application catheter of claim 18, whereinsaid catheter is adapted to travel over a guide member. In yet anotherembodiment of the sling application catheter, the distal end of thecatheter is tapered. In yet another embodiment of the sling applicationcatheter, the distal end of the pouch is tapered. In one embodiment ofthe sling application catheter, the pouch is porous. In anotherembodiment of the sling application catheter, the pouch furthercomprises a stiffener for increasing its rigidity. The stiffener may bein the interior of the pouch or on the exterior of the pouch. In anotherembodiment of the sling application catheter, the stiffener is porous.

[0015] Another aspect of the present invention is a method ofintroducing a sling into a body tissue. The method comprises the stepsof passing a sling application catheter catheter through the bodytissue. The sling application catheter comprises a catheter having asling therein which is releasably engaged to the catheter. The sling isreleased form the sling application catheter, thereby introducing thesling into the body tissue.

[0016] In one aspect of the method of introducing a sling into a bodytissue, the method further comprises making a first incision and asecond incision and the step of passing the sling application catheterthrough the body tissue comprises passing the sling application catheterinto the first incision and out of the second incision. In oneembodiment of the method of introducing a sling into a body tissue, thesling is released from the sling application catheter by withdrawing thesling from a pouch in the sling application catheter. In anotherembodiment, the sling application catheter is passed through the bodytissue over a guide member. In yet another embodiment, the sling isintroduced into the tissue between the urethra and the upper vaginalwall. In still another embodiment, the first incision and the secondincision are suprapubic incisions. In another embodiment, the methodfurther comprises the step of withdrawing the sling from the pouch bygrasping an end of the sling while withdrawing the distal end of thesling application catheter out of the second suprapubic incision. In yetanother embodiment, the step of withdrawing the sling from the pouchcomprises withdrawing a sterile sling.

[0017] Another aspect of the present invention is a tissuedissector/dilator for creating and dilating an opening or pocket in abody tissue. The tissue dissector/dilator comprises a body, anoncompliant shaft attached to the body, a dissector carried on theshaft for creating an opening or pocket in the body tissue, and adilator carried on the shaft for dilating the opening or pocket in thebody tissue. In one. embodiment, the shaft has a lumen extendingtherethrough and the dissector is within the lumen in the shaft and isaxially movable, such that the dissector can be extended from andretracted in the shaft. In another embodiment, the shaft has a lumenextending therethrough and the dilator is within the lumen in the shaftand is axially movable, such that the dilator can be extended from andretracted in said shaft. In another embodiment, the shaft has a lumenextending therethrough and both the dissector and the dilator are withinthe lumen of the shaft and are axially movable, such that the dissectorand the dilator can be extended from and retracted in the shaft. In oneembodiment, the axially movable dissector and the axially movableexpandable dilator are integral. In another embodiment, the tissuedissector/dilator is adapted for use in bladder neck stabilizationprocedures.

[0018] In still another embodiment of the tissue dissector/dilator, thebody of the tissue dissector/dilator further comprises a first controlmember for extending and retracting the axially movable integraldissector and expandable dilator between a first position in which thedissector extends from the shaft, a second position in which both thedissector and the dilator extend from the shaft, and a third position inwhich the dissector and the dilator are retracted inside the shaft. Inthis embodiment, the body of the tissue dissector/dilator also comprisesa second control member for expanding the dilator in the opening orpocket in the body tissue, thereby dilating the opening or pocket andfor collapsing the dilator following dilation of the opening or pocket.In another embodiment, the first control member for extending andretracting the axially movable integral dissector and expandable dilatorcomprises a spring return button which engages the axially movableintegral dissector and expandable dilator so as to extend or retractsaid axially movable integral dissector and expandable dilator. In stillanother embodiment, the spring return button can be positioned to lockthe axially movable integral dissector and expandable dilator in a fullyextended position. In yet another embodiment, the spring return buttonprovides a one to one stroke motion to the axially movable integraldissector and expandable dilator.

[0019] In a further embodiment of the tissue dissector/dilator, theaxially movable integral dissector and expandable dilator is a cathetercomprising an outer tube having a lumen extending therethrough and atleast one expandable balloon in the lumen of the outer tube. In thisembodiment, the expandable balloon has an inflation tube at its proximalend and a blunt dissector at its distal end, wherein the inflation tubeis in fluid communication with the interior of the balloon. In stillanother embodiment, the second control member for expanding the dilatorcomprises a trigger on the body and a syringe in the body comprising aplunger, a reservoir, and a tip. In this embodiment, the tissuedissector/dilator also comprises a syringe locking mechanism, whereinthe tip of the syringe fixedly engages the syringe locking mechanism toplace the reservoir of the syringe in fluid communication with theballoon catheter, and the trigger engages the plunger of the syringesuch that squeezing the trigger depresses the plunger of the syringethereby dispensing fluid from the syringe and expanding the balloon ofthe catheter. In still another embodiment, the catheter furthercomprises a second lumen adapted for passage of a guide member. In afurther embodiment, the catheter further comprises a third lumen. Inanother embodiment, the third lumen is adapted for receiving anultrasound catheter. In still another embodiment, the third lumen isadapted for receiving an implant. In another embodiment, the third lumenis adapted for irrigation.

[0020] Another aspect of the present invention is a tissuedissector/dilator for creating and dilating an opening or pocket in abody tissue comprising a body, a noncompliant shaft attached to saidbody, a dissection means carried on the shaft for dissecting an openingor pocket in a body tissue, and a dilation means carried on the shaftfor dilating the opening or pocket,

[0021] Another aspect of the present invention is a method of creatingand dilating an opening or pocket in a body tissue. A noncompliant shaftof a tissue dissector/dilator is percutaneously inserted into the bodytissue. The shaft is advanced through the body tissue. A dissector isextended from a distal end of the shaft to create a first opening orpocket in the body tissue and a dilator is extended from the distal endof the shaft. The dilator is expanded within the first opening or pocketto dilate the first opening or pocket. In one embodiment of the method,the tissue dissector/dilator is percutaneously inserted through asuprapubic incision. In another embodiment, the body tissue is thetissue between the urethra and the upper vaginal wall and the firstopening or pocket is perpendicular to the longitudinal axis of theurethra and extends from one side of the urethra to the other. Inanother embodiment the method further comprises percutaneously insertinga noncompliant shaft of a second tissue dissector/dilator into the bodytissue, advancing the noncompliant shaft of the second tissuedissector/dilator through the body tissue, extending a dissector from adistal end of the shaft of the second tissue dissector/dilator to createa second opening or pocket in the tissue, extending a dilator from thedistal end of the shaft of the second tissue dissector/dilator andexpanding said dilator within the second opening or pocket, therebydilating the second opening or pocket and forming from the first andsecond openings or pockets a continuous opening or pocket in the bodytissue. In a further embodiment, the second tissue dissector/dilator ispercutaneously inserted through a suprapubic incision. In yet anotherembodiment of the method, the body tissue is the tissue between theurethra and the upper vaginal wall and the continuous opening or pocketis perpendicular to the longitudinal axis of the urethra and extendsfrom one side of the urethra to the other.

[0022] Another aspect of the present invention is a sling applicationdevice for inserting a sling into a pocket in a body tissue. The slingapplication device comprises a first shaft and a second shaft. The firstand second shafts have lumens extending therethrough. The lumens havedimensions adapted for receiving a sling therein. The sling applicationdevice also comprises an adjuster for incrementally adjusting thedistance between said first and second shafts. In one embodiment, thelumens of the first and second shafts have dimensions adapted forreceiving a sling introducer having a sling releasably engaged thereto.In another embodiment, the sling application device further comprises afirst handle attached to the first shaft and a second handle attached tothe second shaft. In this embodiment, the first and second handles haveopenings therein which are in fluid communication with the lumens in theshafts to which the handles are attached and the first and secondhandles are adapted to be connected to one another. In anotherembodiment, the adjuster engages the first and second handles.

[0023] In one embodiment of the sling application device the first andsecond shafts are curved. In still another embodiment, the first andsecond shafts have a small radius 90° curve at their distal ends, suchthat the first and second shafts are adapted for use in urethralstabilization procedures. In another embodiment, the first and secondshafts have a side bend. In yet another embodiment, the radius ofcurvature at the distal ends of the first and second shafts is notplanar with the axial portions of the shafts of the first and secondshafts. In still another embodiment, the upper edges of the distal endsof the first and second shafts are indented relative to the lower edges.In another embodiment, the first and second handles are adapted forinterlocking. In a further embodiment, the adjuster comprises anarticulating lock. In still another embodiment, the first shaft and thesecond shaft are cylindrical. In one embodiment, the first shaft and thesecond shaft comprise flat tubes. In another embodiment, the portion ofthe first shaft and the second shaft proximal to the bend is cylindricaland the portion distal to the bend is a flat tube. In anotherembodiment, the proximal portions of the first and second shafts areoriented at an angle of about 90° relative to the distal portions of thefirst and second shafts. In another embodiment, the sling applicationdevice further comprises a blunt dissector for dissecting the bodytissue without scoring or creasing tissue or bone with which it comes incontact. In this embodiment, the blunt dissector comprises a dissectorshaft adapted for insertion into the first and second shafts of thesling application device. The dissector shaft has a generally rigid tipat its distal end. The rigid tip protrudes from the distal ends of thefirst and second shafts of the sling application device when the bluntdissector is inserted into the first and second shafts of the slingapplication device. In yet another embodiment, the blunt dissectorcomprises an obturator.

[0024] Another aspect of the present invention is a sling introduceradapted for introducing a sling attached thereto into an opening orpocket in a body tissue without the use of sutures. The sling introducercomprises a sling engager having the sling releasably engaged thereto.The sling engager is adapted for advancement through a first shaft and asecond shaft of a sling application device. The length of the slingintroducer is at least equal to the sum of the lengths of the first andsecond shafts of the sling application device. In one embodiment, thesling engager comprises a pouch for releasably engaging said sling. Inanother embodiment, the pouch has pores therein for permitting asolution to access said sling. In still another embodiment, the distalend of the pouch has a narrow lead. In a further embodiment, the pouchis reinforced.

[0025] Another aspect of the present invention is a tissue cutter forforming a cavity in a tissue. The tissue cutter comprises an elongatedhousing adapted to fit within a shaft of a sling application device andan extendable and a retractable blade within the housing. The blade isadapted to form the cavity in the tissue. In one embodiment, the bladecomprises a razor. In another embodiment, the razor is sized such thatthe cavity formed with the razor has dimensions adapted for insertion ofa sling therein.

[0026] Another aspect of the present invention is a sling applicationsystem. The sling application system includes a sling application devicecomprising a first shaft and a second shaft. The first and second shaftsof the sling application device have lumens extending therethrough. Thelumens have dimensions adapted for receiving a sling introducer therein.The sling application device also comprises an adjuster forincrementally adjusting the distance between the first and secondshafts. The sling application system also includes a blunt dissector fordissecting a body tissue without scoring or creasing tissue or bone withwhich it comes in contact. The blunt dissector comprises a dissectorshaft adapted for insertion into the first and second shafts of thesling application device. The dissector shaft has a generally rigid tipat its distal end wherein the generally rigid tip protrudes from thedistal ends of the first and second shafts of the sling applicationdevice when the blunt dissector is inserted into the first and secondshafts. The sling application system also comprises a sling introducerfor introducing a sling attached thereto into an opening or pocket inthe body tissue without the use of sutures. The sling introducercomprises a sling engager having the sling releasably engaged thereto.The sling engager is adapted for advancement through the lumens of thefirst and second shafts of the sling application device wherein thesling introducer has a length sufficient to extend between the first andsecond shafts of the sling application device. In one embodiment, thesling application system further comprises a tissue cutter for forming acavity in the body tissue. The tissue cutter comprises an elongatedhousing adapted to fit within the second shaft of the sling applicationdevice and an extendable and retractable blade within the housing. Theblade is adapted to form a cavity in the body tissue.

[0027] Yet another aspect of the present invention is a method forintroducing a sling into a body tissue. A first blunt dissector isinserted into a first shaft of a sling application device. The firstshaft having the first blunt dissector therein is insertedpercutaneously and advanced through the body tissue. A second bluntdissector is inserted into a second shaft of the sling applicationdevice. The second shaft having the second blunt dissector therein isinserted percutaneously and advanced through the body tissue. Thedistance between the distal ends of said first and second shafts isdecreased. A sling introducer having the sling releasably engagedthereto is advanced between the first and second shafts of the slingapplication device. The sling is released from the sling introducer. Thefirst and second shafts are removed from the body tissue, therebyintroducing the sling into the body tissue. In one embodiment, themethod further comprises making a first incision and a second incisionwherein the first shaft of the sling application device is inserted intothe first incision prior to advancing it through the body tissue and thesecond shaft of the sling application device is inserted into the secondincision prior to advancing it through the body tissue. In anotherembodiment, the sling is introduced into a pre-formed pocket in thetissue between the urethra and the vaginal wall. In a furtherembodiment, the first incision and the second incision are suprapubicincisions. In still another embodiment, the method further comprisesinserting a tissue cutter into the first shaft of the sling applicationdevice and extending the tissue cutter into the body tissue between thedistal ends of the first and second shafts, thereby dissecting the bodytissue.

[0028] Another aspect of the present invention is a balloon cathetercomprising an outer tube having a lumen extending therethrough and atleast one expandable balloon adapted for dilating an opening or pocketin the tissue between the urethra and the upper vaginal wall. Theexpandable balloon has a proximal end and a distal end in the lumen ofthe outer tube. The expandable balloon also has an inflation tube at itsproximal end. The inflation tube is in fluid communication with theinterior of the balloon. In one embodiment, the expandable balloon has ablunt dissection tip at its distal end which has sufficient rigidity toallow it to create an opening or pocket in the solid body tissue. In oneembodiment, the balloon catheter comprises a plurality of expandableballoons in fluid communication with the inflation tube. In anotherembodiment, the balloon catheter is adapted to fit in the lumen of alarge bore needle. In still another embodiment, the expandable balloonhas a flat profile. In another embodiment, the balloon further comprisesinternal non-expansive ribs. In yet another embodiment, the catheterextends into the interior of the balloon. In still another embodiment,the balloon is on the exterior surface of the catheter.

[0029] Another aspect of the present invention is a detachable membersling application device for introducing a sling having sutures attachedthereto into an opening or pocket in a body tissue. The detachablemember sling application device has a housing with an introduction shaftconnected thereto. The introduction shaft has a lumen extendingtherethrough which is adapted to receive the sling having suturesattached thereto. The detachable member sling application device alsohas a detachable member on the distal end of the introduction shaft. Thedetachable member is connected to at least one of the sutures attachedto the sling. In one embodiment, the detachable member sling applicationdevice further comprises an axially movable needle. In this embodiment,the needle comprises a needle shaft and a sharpened point. The needle islocated inside the lumen of the introduction shaft and is extendabletherefrom.

[0030] Another aspect of the present invention is a retrieval device forintroducing a sling into an opening or pocket in a body tissue,comprising a shaft having an engaging member at its distal end. Theengaging member is adapted to engage a detachable member connected to asuture attached to the sling.

[0031] Another aspect of the present invention is a method ofstabilizing the bladder neck. A pocket or opening is formed in thetissue between the urethra and the upper vaginal wall. A slingapplication device is inserted into the pocket or opening. A sling isintroduced into the pocket or opening with the sling application device.The sling is secured to tissue or bone to stabilize the bladder neck. Inone embodiment the method further comprises providing a detachablemember sling application device. The detachable member sling applicationdevice has a housing with an introduction shaft connected thereto. Theintroduction shaft has a lumen extending therethrough which is adaptedto receive the sling having sutures attached thereto. The detachablemember sling application device also has a detachable member on thedistal end of the introduction shaft. The detachable member is connectedto at least one of the sutures attached to the sling. In thisembodiment, the step of inserting a sling application device into thepocket or opening comprises inserting the detachable member slingapplication device into the opening or pocket. Another step in thisembodiment comprises detaching a detachable member from a distal end ofthe shaft of the detachable member sling application device. Thedetachable member is connected to the sling. Another step in thisembodiment comprises introducing a shaft of a retrieval device into theopening or pocket. Yet another step in this embodiment comprisesengaging the detachable member with an engaging member on the shaft ofthe retrieval device. Another step of this embodiment compriseswithdrawing the shaft of the retrieval device from the opening orpocket, thereby introducing the sling of the detachable member slingapplication device into the opening or pocket. In another embodiment,the method further comprises extending an axially movable needle from adistal end of the shaft of the detachable member sling applicationdevice into the body tissue and toggling the needle to move thedetachable member within the opening or pocket. In still anotherembodiment, the opening or pocket is in a hiatus between a urethra andan upper vaginal wall. In another embodiment, the method furthercomprises the step of expanding the opening or pocket in the hiatususing a balloon catheter having at least one expandable balloon with ablunt dissection tip at its distal end. In this embodiment, the bluntdissection tip has sufficient rigidity to allow it to make the openingin the body tissue when contacting the tissue.

[0032] Another aspect of the present invention is a device for expandingan opening or pocket within a body tissue. The device comprises a tubehaving a lumen extending therethrough, an axially movable expandable andcollapsible expansion basket attached to the tube for insertion into theopening or pocket within the body tissue and expansion thereof, and anexpansion and collapse control in communication with the expandable andcollapsible basket for expanding and collapsing the basket. In oneembodiment, the basket comprises a plurality of wires. In anotherembodiment, the expansion and collapse control comprises a pull wire.

[0033] Another aspect of the present invention is a grasping deviceadapted for insertion into a lumen of an expansion device having anexpansion basket for expanding an opening or pocket within a bodytissue. The grasping device comprises a catheter having a graspingmember on its distal end for grasping a suture or guide member which hasbeen advanced into the expansion basket of the expansion device. In oneembodiment, the grasping member comprises a self-expanding basket. Inanother embodiment, the self-expanding basket is adapted to fit insidethe expansion basket of the expansion device when the expansion basketof the expansion device is in an expanded configuration.

[0034] Another aspect of the present invention is a method of creating apocket in the tissue between the urethra and the upper vaginal wallcomprising hydrodissecting the tissue.

[0035] Another aspect of the present invention is a method for holding apocket in a body tissue in an open position. A lumen is made in the bodytissue. The lumen in the body tissue is expanded to create the pocket inthe body tissue. An expansion device is inserted into the pocket and anexpansion basket on the expansion device is expanded in the pocket,thereby holding the pocket in the open position. In one embodiment, thebody tissue comprises a hiatus between a urethra and an upper vaginalwall. In another embodiment, the lumen is expanded with a ballooncatheter. In another embodiment, the method further comprises insertinga suture or guide member through a suprapubic incision into the pocket,inserting a grasping device comprising a catheter having a graspingmember on its distal end into a lumen of the expansion device, graspingthe suture or guide member with the grasping device, and withdrawing thesuture or guide member to a desired position. In one embodiment, thesuture or guide member is grasped under direct vision.

[0036] Yet another aspect of the invention is a method of introducing asling into an opening in a body tissue comprising holding a pocket oropening in a body tissue in an open position with an expansion basket asdescribed above, grasping a suture or guidewire within the expandedopening as described above, and drawing the suture or guidewire to adesired position. The method is performed on each side of the urethrasuch that two sutures extend from the patient's body. The two suturesare tied together and used to guide a sling into the opening. In oneembodiment, the body tissue comprises a hiatus between the urethra andthe upper vaginal wall.

[0037] Yet another aspect of the invention is a method of introducing asling into an opening in a body tissue comprising holding a pocket oropening in a body tissue in an open position with an expansion basket asdescribed above, grasping a suture or guidewire within the expandedopening as described above, and drawing the suture or guidewire to adesired position. The method is performed on each side of the urethrasuch that two sutures extend from the patient's body. A sling isattached to the two sutures outside of the patient's body and introducedinto the opening in the body tissue. In one embodiment, the body tissuecomprises a hiatus between the urethra and the upper vaginal wall.

BRIEF DESCRIPTION OF THE DRAWINGS

[0038]FIG. 1 is a side view of an embodiment of a guide member placementdevice having a male connector at the distal end of the shaft.

[0039]FIG. 2 is an assembled cross-sectional view of the guide memberplacement device of FIG. 1 showing the internal structure of the device.

[0040]FIG. 3 is a side view of an embodiment of a guide member placementdevice having a female connector at the distal end of the shaft.

[0041]FIG. 4 is an enlarged cross-sectional view taken along line 4-4 ofthe distal end of the shaft of a guide member placement device of FIG.1.

[0042]FIG. 5 is an enlarged cross-sectional view taken along line 5-5 ofthe distal end of the shaft of the guide member placement device of FIG.3.

[0043]FIG. 6 is a cross-sectional view showing the distal ends of theshafts of the guide member placement devices of FIGS. 1 and 3 coupledthrough their male and female connectors.

[0044]FIG. 7A is an enlarged view of the distal portion of the shaft ofthe guide member placement device taken along line 7A-7A of FIG. 1.

[0045]FIG. 7B is an enlarged view of the distal portion of the shaft ofthe guide member placement device taken along line 7B-7B of FIG. 3.

[0046]FIG. 7C is an enlarged view of the distal portion of the shaft ofa guide member placement device having an alternate shaft configurationin which the curve is smoothly curved.

[0047]FIG. 7D is an enlarged view of the distal end of the shaft of aguide member placement device having an alternate shaft configuration inwhich the curve is smoothly curved.

[0048]FIG. 8 shows the blunt dissection tip extending into a tissue fromthe distal end of the shaft of a guide member placement device having amale connector to create an opening in the tissue.

[0049]FIG. 9 shows a first guide member placement device that has beeninserted into a first suprapubic incision and advanced into the bodytissue.

[0050]FIG. 10 shows a guide member placement device that has beenadvanced into the tissue between the urethra and the upper vaginal wallsuch that the distal end of the shaft extends transversely between theurethra and the upper vaginal wall in the plane defined by thelongitudinal axes of the urethra and the vagina.

[0051]FIG. 11 shows the blunt dissection tip extending into a tissuefrom the distal end of the shaft of a guide member placement devicehaving a female connector to create an opening in the tissue.

[0052]FIG. 12 shows a second guide member placement device that has beeninserted into a second suprapubic incision and advanced into a bodytissue.

[0053]FIG. 13 shows the first and second guide member placement devicesin the tissue between the urethra and the upper vaginal wall with thedistal ends of their shafts connected to one another.

[0054]FIG. 14 shows a guide member extending between the two suprapubicincisions after removal of the first and second guide member placementdevices.

[0055]FIG. 15 is a plan view of a sling application catheter.

[0056]FIG. 16 is an enlarged view of the distal end of the slingapplication catheter taken along line 16-16 of FIG. 15.

[0057]FIG. 17 is a cross-sectional view taken along line 17-17 of thesling application catheter of FIG. 16.

[0058]FIG. 18 is an enlarged view of the distal end of a slingapplication catheter having a reinforcing stiffener within the pouch.

[0059]FIG. 19 is a cross-sectional view taken along line 19-19 of thesling application catheter of FIG. 18.

[0060]FIG. 20 is an enlarged view of the distal end of a slingapplication catheter having a pouch made of a porous material.

[0061]FIG. 21 shows a sling application catheter being inserted into afirst suprapubic incision with a guide member extending through thelumen of the catheter.

[0062]FIG. 22 shows the sling being withdrawn from the pouch of a slingapplication catheter that has been advanced into the tissue between theurethra and the upper vaginal wall.

[0063]FIG. 23 shows the sling extending between the first and secondsuprapubic incisions and passing through the tissue between the urethraand the upper vaginal wall.

[0064]FIG. 24 is a plan view of a tissue dissector/dilator in which thespring return button is at the most proximal point and the bluntdissection tip and the expandable balloon are retracted within theshaft.

[0065]FIG. 25 is a plan view of the tissue dissector/dilator in whichthe spring return button has been advanced to the locked position andthe expandable balloon and blunt dissection tip are fully extended fromthe shaft.

[0066]FIG. 26 is a side view of a balloon catheter with a bluntdissection tip at its distal end.

[0067]FIG. 27 is a plan view of a tissue dissector/dilator in which thespring return button has been advanced towards the distal end of theslide and the blunt dissection tip extends from the shaft.

[0068]FIG. 28 is a plan view a tissue dissector/dilator in which thetrigger has been squeezed, causing the balloon to inflate.

[0069]FIG. 29 is a plan view of an alternate embodiment of the tissuedissector/dilator.

[0070]FIG. 30 shows the distal end of the shaft of a tissuedissector/dilator being advanced until it intersects the tissue betweenthe urethra and the upper vaginal wall at approximately mid-thicknessand in a direction which would permit the expandable balloon to advanceperpendicular to the axial direction of the urethra

[0071]FIG. 31 shows the blunt dissection tip being extended from thedistal end of the shaft into the tissue between the urethra and theupper vaginal wall thereby dissecting a first opening in the tissue.

[0072]FIG. 32 shows the expandable balloon extended into the firstopening in the tissue between the urethra and the upper vaginal wallwhich was created with the blunt dissection tip.

[0073]FIG. 33 shows the balloon being expanded in the first opening inthe tissue thereby dilating the first opening.

[0074]FIG. 34 shows a second tissue dissector/dilator with its blunt tipdissecting a second opening in the tissue between the urethra and theupper vaginal wall which is aligned with the first opening in thetissue.

[0075]FIG. 35 shows the expandable balloon extended into the secondopening.

[0076]FIG. 36 shows the expandable balloon expanded within the secondopening thereby dilating the body tissue.

[0077]FIG. 37 shows a continuous opening in the tissue between theurethra and the upper vaginal wall.

[0078]FIG. 38A is a perspective view of a sling application device.

[0079]FIG. 38B is a plan view taken along line 38B-38B of the slingapplication device of FIG. 38A showing the tab on the locking button.

[0080]FIG. 39 is a side-view of the sling application device.

[0081]FIG. 40 is a cross-sectional view taken along line 40-40 of thefirst shaft of the sling application device of FIG. 39.

[0082]FIG. 41 is a cross-sectional view taken along line 41-41 of thesecond shaft of the sling application device of FIG. 40.

[0083]FIG. 42 is a side view of an alternate embodiment of the slingapplication device in which the portion of the shafts proximal to thebend is cylindrical and the portion of the shafts distal to the bend isa flat tube.

[0084]FIG. 43 is a cross-sectional view taken along line 43-43 of theportion of the first shaft distal to the bend of the sling applicationdevice of FIG. 42.

[0085]FIG. 44 is a cross-sectional view taken along line 44-44 of theportion of the first shaft proximal to the bend of the sling applicationdevice of FIG. 42.

[0086]FIG. 45 is a side view of an alternate embodiment of the slingapplication in which the shafts are flat along their entire length.

[0087]FIG. 46 is a cross-sectional view taken along line 46-46 of thefirst shaft of the sling application device of FIG. 45.

[0088]FIG. 47 is a side view of an alternate embodiment of the slingapplication device in which the shafts have a side bend.

[0089]FIG. 47A is a plan view of the first shaft taken along line47A-47A of the sling application device of FIG. 47.

[0090]FIG. 47B is a plan view of the second shaft taken along line47B-47B of the sling application device of FIG. 47.

[0091]FIG. 48 is a side view of a sling application device in which theshafts have a 90° twist.

[0092]FIG. 49 is a perspective view of the distal ends of the first andsecond shafts of a sling application device in which the upper edges ofthe distal ends of the shafts are slightly indented relative to thelower edges.

[0093]FIG. 50 is a side view of an obturator for use with the slingapplication device.

[0094]FIG. 51 is a plan-view of a sling introducer.

[0095]FIG. 52 is a cross-sectional view taken along line 52-52 of thesling introducer of FIG. 51.

[0096]FIG. 53 is a cross-sectional view of a cutter showing the internalstructure of the device.

[0097]FIG. 54 shows the first shaft of the sling application devicebeing advanced into a pre-formed opening in the tissue between theurethra and the upper vaginal wall.

[0098]FIG. 55 shows the distal ends of the first and second shafts ofthe sling application device opposing each other in the opening intissue between the urethra and the upper vaginal wall.

[0099]FIG. 56 shows the first and second handles of the slingapplication device locked together.

[0100]FIG. 57 shows the distance between the distal ends of the firstand second shafts of the sling application device being decreased as theadjuster is advanced to a position in between the proximal point and thedistal point of the guide.

[0101]FIG. 58 shows the tissue between the distal ends of the first andsecond shafts of the sling application device being compressed when theadjuster is advanced to the distal end of the guide.

[0102]FIG. 59 shows an opening in the tissue between the urethra and theupper vaginal wall being created by a cutter dissecting the tissuebetween the distal ends of the first and second shafts of the slingapplication device.

[0103]FIG. 60 shows the sling introducer being inserted into the secondshaft of the sling application device.

[0104]FIG. 61 shows the sling being withdrawn from the sling introduceras the sling introducer is advanced through the tissue between theurethra and the upper vaginal wall.

[0105]FIG. 62 shows the sling fully withdrawn from the sling introducerand located within the first and second shafts of the sling applicationdevice.

[0106]FIG. 63 shows the second shaft of the sling application devicebeing removed from the patient's body.

[0107]FIG. 64 shows the first shaft of the sling application devicebeing removed from the patient's body.

[0108]FIG. 65 shows the sling extending between the suprapubic incisionsand passing through the tissue between the urethra and the upper vaginalwall.

[0109]FIG. 66 is a side view of a detachable member sling applicationdevice.

[0110]FIG. 67 is a side view of a retrieval device.

[0111]FIG. 68 shows the creation of an opening in the tissue between theurethra and the upper vaginal wall by hydrodissection.

[0112]FIG. 69 shows the shaft of a detachable member sling applicationdevice sling application device being advanced to a pocket or opening inthe tissue between the urethra and the upper vaginal wall.

[0113]FIG. 70 shows the sharpened point of the needle of the detachablemember sling application device extending through the upper vaginalwall.

[0114]FIG. 71 shows the needle of the detachable member slingapplication device being secured on the vaginal side with a hemostat.

[0115]FIG. 72 shows the detachable cup being detached from the distalend of the shaft of the detachable member sling application device.

[0116]FIG. 73 shows the needle of the detachable member slingapplication device being toggled.

[0117]FIG. 74 shows the shaft of a retrieval device being advancedthrough a second suprapubic incision into the pocket.

[0118]FIG. 75 shows the shaft of the retrieval device being insertedinto the detachable cup and engaging the detachable cup.

[0119]FIG. 76 shows the needle being removed from the vagina.

[0120]FIG. 77 shows the sutures connected to the sling being pulled outof the shaft of the detachable cup sling application device.

[0121]FIG. 78 shows the shaft of the retrieval device being withdrawnfrom the pocket or opening, pulling the sling out of the shaft of thedetachable member sling application device.

[0122]FIG. 79 shows the shafts of the retrieval device and thedetachable member sling application device being withdrawn from thepocket.

[0123]FIG. 80 shows the sling located in the opening in the tissuebetween the urethra and the upper vaginal wall with the suturesextending through the incisions to the outside of the patient's body.

[0124]FIG. 81 shows the marks on the sutures being aligned to ensurecentering of the sling beneath the urethra within the opening in thetissue between the urethra and the upper vaginal wall.

[0125]FIG. 82 is a side view of a balloon catheter having two expandableballoons joined at their distal ends.

[0126]FIG. 83 shows the balloon catheter of FIG. 82 with the balloonsexpanded.

[0127]FIG. 84 is a plan view of the balloon catheter having a flatprofile balloon.

[0128]FIG. 85 is a cross-sectional view taken along line 85-85 of theballoon catheter of FIG. 84.

[0129]FIG. 86 is a cross-sectional view taken along line 86-86 of theballoon catheter of FIG. 84.

[0130]FIG. 87 is a cross-sectional view of a tissue expander.

[0131]FIG. 88 is a side view of a grasping device.

[0132]FIG. 89 shows the target site for insertion of a device forcreating a lumen in the hiatal tissue between the urethra and the uppervaginal wall.

[0133]FIG. 90 shows the urethra straightened with a Foley catheter.

[0134]FIG. 91 shows a large bore needle being inserted into the hiataltissue between the urethra and the upper vaginal wall.

[0135]FIG. 92 shows the needle partially retracted such that the lumencreated by the needle provides an access channel.

[0136]FIG. 93 shows a balloon catheter being advanced beyond the tip ofthe needle into the lumen created in the hiatal tissue.

[0137]FIG. 94 shows the balloon of the balloon catheter being inflatedto dilate the tissue around the lumen created in the hiatal tissue.

[0138]FIG. 95 shows the tissue expander being advanced beyond the tip ofthe needle into the lumen created in the hiatal tissue.

[0139]FIG. 96 shows the tissue expander in the expanded configurationwithin the lumen created in the hiatal tissue.

[0140]FIG. 97 shows a suture passing through the expansion basket of thetissue expander and into the self expanding basket of the graspingdevice.

[0141]FIG. 98 shows the grasping device grasping the suture.

[0142]FIG. 99 shows the grasping device being withdrawn from the rigidtube and drawing the suture towards the outside of the patient's body.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0143] The present invention relates to methods and devices for creatingopenings or pockets in body tissues and/or dilating body tissues. Theguide member placement devices, sling application catheters, tissuedissector/dilators, sling application devices, sling applicationsystems, detachable member sling application devices, retrieval devices,and balloon catheters of the present invention may be usedpercutaneously or in conjunction with laparoscopic techniques. In suchlaparoscopic procedures, trocars are placed in the abdomen and theabdomen is insufflated with CO₂, causing it to distend. The devices areintroduced into the patient's body via the trocars, and the procedure isvisualized with a laparoscope.

[0144] The devices of the present invention may be used in a widevariety of medical procedures, but are particularly well suited forurethral floor reconstruction procedures such as bladder neckstabilization or suspension procedures in which a sling is used tomaintain or improve urinary continence by stabilizing and/or slightlycompressing the urethra or by creating a non-moveable pelvic floor.Slings suitable for use in bladder neck stabilization procedures andmethods for implanting them are disclosed in the copending U.S. PatentApplication entitled “Stabilization Sling for Use in Minimally InvasivePelvic Surgery” (VESITEC.023A), filed simultaneously herewith, and theidentically titled U.S. Provisional Patent Application Serial No.60/038,379, filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference.

[0145] The present invention is particularly well suited for bladderneck stabilization procedures for treating urinary incontinence infemales. The bladder neck stabilization procedures for which the presentinvention is especially well suited involve the creation of an openingor pocket in the tissue between the urethra and the upper vaginal wall,which is called the hiatus. The sling is then inserted in the opening orpocket. Sutures or integral attachment members at the ends of the slingare attached to the pubic bone or surrounding tissue and the tension isadjusted to slightly compress or stabilize the urethra by providing aplatform to reduce distension resulting from internal pressures, therebymaintaining or improving urinary continence. Suitable methods anddevices for adjusting the tension on the sutures are disclosed in U.S.Pat. No. 5,611,515, issued Mar. 18, 1997 to Benderev et al., thedisclosure of which is incorporated herein by reference.

[0146] The opening or pocket may be created in a variety of ways. In oneapproach, the opening or pocket is created by introducing an expandableballoon into the tissue between the urethra and the upper vaginal wall.When the balloon is expanded, the surrounding tissue is dilated or torn,generating an opening or pocket of sufficient size to receive the sling.

[0147] In an alternative approach, the opening or pocket is created byhydrodissection. In this approach, a bolus of saline or other sterilesolution is injected into the tissue between the urethra and the uppervaginal wall, resulting in an opening or pocket sized to receive thesling. The bolus of saline may be administered by positioning a syringeinside the vagina and piercing the vaginal wall with the needle of thesyringe such that the tip of the needle is in the tissue between theurethra and the upper vaginal wall. Alternatively, the bolus of salinemay be administered directly into the hiatal tissue without piercing thevaginal wall.

[0148] The volume of saline injected into the tissue in thehydrodissection procedure is too large to be rapidly absorbed such thatthe tissue must separate to accommodate the saline bolus. Preferably,the volume of saline introduced into the tissue is from about 4 cc toabout 10 cc. More preferably, the volume of saline is about 4 to about 5cc.

[0149] In yet another approach, the opening or pocket is created bydissecting the tissue between the urethra and the upper vaginal wallwith a combination of blunt dissectors and sharp cutters.

[0150] The opening or pocket may be created and the sling may beintroduced by taking a variety of routes through the patient's body. Inone approach, called the percutaneous approach, the opening or pocket iscreated by making suprapubic incisions into which a device forintroducing an opening or pocket in a body tissue or dilating a bodytissue is inserted. The device is advanced through the patient's bodytissue into the tissue between the urethra and the upper vaginal wallwhere the opening or pocket is to be created. In some instances, thedevice for introducing an opening or pocket in a body tissue or dilatinga body tissue may also introduce the sling into the opening.

[0151] In another approach, called the hiatal approach, the opening orpocket is created and the sling is introduced by directly accessing thetissue between the urethra and the upper vaginal wall. In this procedurethe opening or pocket can be created without making suprapubic orvaginal incisions.

[0152] In other approaches, the opening or pocket is created directly inthe tissue between the urethra and the upper vaginal wall and the slingis introduced with a device advanced into the opening or pocket from asuprapubic or vaginal incision.

[0153] The devices and procedures described briefly above are discussedin greater detail in the following sections. It will be appreciated bythose of skill in the art that any of the disclosed devices and methodsfor creating an opening or pocket can be combined with any of thedisclosed devices and methods for introducing a sling into the openingor pocket.

Guide Member Placement Device

[0154] One aspect of the present invention relates to methods in whichthe sling is introduced over a guide member and devices for use in suchmethods. The guide member may be a suture, guidewire, or other structuresuitable for guiding a sling to a desired location.

[0155] In one embodiment, the opening or pocket in which the sling isintroduced is created first and the guide member is then passed throughthe opening or pocket. In this embodiment, the opening or pocket may becreated using any of the techniques disclosed herein, includingexpandable balloons and hydrodissection.

[0156] Alternatively, the opening or pocket may be created during guidemember placement by extending and retracting a blunt dissector on aguide member placement device.

[0157] In yet another embodiment, the opening or pocket in which thesling is introduced is created by the sling application catheterdisclosed herein after the guide member is positioned.

[0158] Devices and methods for using a guide member to introduce a slingin the tissue between the urethra and the upper vaginal wall will now bediscussed in greater detail.

[0159] One aspect of the present invention relates to guide memberplacement devices for applying a guide member under the urethra in aless invasive manner without puncturing the vaginal wall.

[0160] In general, the guide member placement device comprises a shafthaving a proximal end, a distal end, and a lumen extending therethrough.The lumen is adapted for receiving a guide member.

[0161] Preferably, the shaft is rigid. It is also preferred that theproximal end of the shaft is attached to a handle having a lumenextending therethrough. Preferably, the guide member placement devicehas a blunt dissection tip with a lumen extending therethrough. Theblunt dissection tip is preferably located at the distal end of theshaft. It is also preferred that the blunt dissection tip is on a bluntdissector which is within the shaft and is extendable from andretractable in the shaft.

[0162] Preferably, the lumen in the blunt dissector is in fluidcommunication with the lumen in the handle. Preferably, the bluntdissector is axially movable and can be extended from and retracted inthe shaft. Preferably, the blunt dissector is made of rigid plastic orflexible metal. For example, the blunt dissector may be a coil ofstainless steel. The blunt dissector may be solid and may be made ofmetals such as stainless steel, spring steel, Elgiloy, Nitinol, or othergenerally elastic metals. The blunt dissector may also be a rigidplastic such as nylon or Acrylonitrile Butadiene Styrene (ABS).

[0163] The guide member placement device has an engaging member at thedistal end of the shaft which is complementary to or otherwise adaptedto be attached to an engaging member at the distal end of the shaft of asecond guide member placement device, such that the shafts of the twoguide member placement devices can be attached to one another with thelumens of the blunt dissectors in each shaft in fluid communication withone another.

[0164] Referring to FIGS. 1, 2 and 3, there are disclosed guide memberplacement devices 10, 1910 in accordance with one aspect of the presentinvention. Handle 12, 1912 serves both as a gripping area for thephysician and as a support structure for the guide member placementdevice. Handle 12, 1912 preferably comprises a hollow tubular body 13,1913. The handle 12, 1912 is preferably of such a size to be easilygripped by a user. For instance, in one embodiment, the handle isapproximately .75 inches (20 mm) in diameter and approximately 4 inches(110 mm) in length. Preferably, handle 12, 1912 is provided withknurling or other surface texturing to produce a high friction grippingsurface.

[0165] A support 20, 1920 is preferably mounted such that it extendsfrom the distal end of the handle 12, 1912 to provide a mounting supportfor the shaft 22, 1922. The support 20, 1920 acts as a transition memberfrom the handle 12, 1912 to support the shaft 22, 1922.

[0166] The shaft 22, 1922 is an elongate member with its proximal endinserted within or secured to the support 20, 1920. The shaft 22, 1922may be attached to the support 20, 1920 in any variety of manners,including brazing, threading or other means well known to those of skillin the art.

[0167] The shaft 22, 1922 extends distally from the support 20, 1920 andis preferably within the range of from about 6 inches to about 10 inchesin length.

[0168] The shaft 22, 1922 has a lumen 30 extending therethrough. Apreferred embodiment of the distal end of the shaft is shown in FIGS. 7Aand 7B. In this embodiment, the shaft 22, 1922 has a straight proximalsection 23, 1923, a bent intermediate section 25, 1925, and a distal end27, 1927. In an alternate embodiment, the shaft 2122, 2222 may besmoothly curved as shown in FIGS. 7C and 7D. In the embodiments of FIGS.7A-7D, the distal end of the shaft is preferably oriented at an angle of90° relative to the straight proximal section of the shaft. Preferably,the curve of the shaft is smooth to facilitate movement of the bluntdissector 32 within the shaft.

[0169] As will be understood by one of skill in the art, the dimensionsand curvature of the shaft 22, 1922 may vary depending on anatomicalconsiderations and the type of procedure in which it is intended to beused.

[0170] The distal ends 27, 1927 of the shafts 22, 1922 of the guidemember placement devices 10, 1910 are provided with engaging members 28,1928 which are complementary to each other, such that the shafts 22,1922 of the two guide member placement devices 10, 1910 are adapted tobe attached to one another. In one embodiment of the guide memberplacement device 10, depicted in FIGS. 1 and 2, the engaging membercomprises a male connector 17 as illustrated in the enlargedcross-sectional view of FIG. 4. The male connector 17 on the guidemember placement device 10 shown in FIGS. 1 and 2 is complementary tothe female connector 1915 on the guide member placement device 1910shown in FIG. 3 and shown in the enlarged cross-sectional view in FIG.5. As shown in the enlarged cross-sectional view of FIG. 6, the maleconnector 17 on the guide member placement device 10 of FIGS. 1, 2 and 4engages the female connector 1915 on the guide member placement device1910 of FIGS. 3 and 5 and attaches the two guide member placementdevices 10, 1910 together such that the lumens 42, 1942 of the bluntdissectors 32, 1932 of each of the two devices are in fluidcommunication with one another. When desired, the male connector 17disengages from the female connector 1915, permitting the two guidemember placement devices 10, 1910 to be separated.

[0171] While the complementary engaging members 28, 1928 of theembodiments shown in FIGS. 1-5 are male and female connectors, thoseskilled in the art will appreciate that a number of alternativeconfigurations can be employed for the engaging members, and the presentinvention contemplates such alternative configurations.

[0172]FIG. 2 is a cross-sectional view showing the internal structure ofthe guide member placement device 10 having a male connecter at thedistal end of the shaft. The internal structure of the embodiment of theguide member placement device 1910 having a female connector at the endof the shaft is similar to that shown in FIG. 2. Thus, the internalstructure will only be described with respect to the device having amale connector.

[0173] As shown in FIG. 2, the handle 12 has a proximal end wall 14 anda distal end wall 16. The support 20 as illustrated is provided with agenerally cylindrical proximal section 24 for engagement within thedistal end of the handle 12 and a tapered distal section 26 for securingthe shaft.

[0174] The shaft 22 is preferably no more than about 0.1 inches (2.5 mm)in diameter and is provided with at least one central lumen 30 foracceptance of an axially movable blunt dissector 32. The blunt dissector32 is mounted within the handle 12 and extends through the support 20and the shaft 22. The blunt dissector 32 is preferably provided at itsproximal end with a relatively large diameter body portion 34 adaptedfor reciprocal motion within tubular handle 12. Body portion 34 ispreferably provided with a slightly smaller diameter recessed portion 36for receiving a return spring 38 which biases the blunt dissector 32 inthe proximal direction and has a lumen 40 extending therethrough whichis in fluid communication with the lumen 42 of the narrow portion of theblunt dissector. Alternatively, any of a variety of well known means canbe utilized to provide a proximal bias on the blunt dissector 32.

[0175] The length of body portion 34 is less than the axial length ofthe cavity within handle portion so that the body portion 34 has anaxial range of motion within the range of from about 2 mm to about 10mm, and preferably about 0.12 inch (3 mm). The proximal end wall 44 ofthe support 20 which extends into the handle 12 acts as one limitingstop for distal travel of body portion 34. The distal surface of the endwall 14 of the handle limits proximal travel of body portion 34. Spring38 pushes against an annular shoulder 46 on body portion 34, biasing theblunt dissector 32 proximally.

[0176] The distal end of blunt dissector 32 is provided with a bluntdissection tip 48 having a lumen therethrough. Spring 38 normally biasesthe blunt dissector 32 towards a first retracted position within thedistal end of shaft 22 such that the blunt dissection tip 48 does notextend from the shaft 22. Axial distal force on body portion 34 extendsthe blunt dissection tip 48 into a second position in which it extendsfrom the shaft 22. Although the blunt dissection tip 48 may be extendedand retracted in any number of ways, such as by use of a knob or button,it is preferred that a rotatable cam 50 be used.

[0177] The cam 50 is attached to a post 54 extending proximally from thehandle 12 and having a lumen 18 therein which is in fluid communicationwith the lumen 40 in the recessed position of the blunt dissector andthe lumen 42 in the narrow portion of the blunt dissector. The cam 50 isrotatably mounted about a pin 56 which extends along an axisperpendicular to the longitudinal axis of the shaft 22. The proximal endof the body portion has a rod 19 which extends proximally through anopening in the proximal end wall 14 of the handle.

[0178] The cam 50 has at least a two position engaging surface which,when rotated into position, engages the rod 19 of the body portion. In afirst position, the cam 50 is biased by the return spring 38 to aposition in which the blunt dissection tip 48 is fully retracted withinthe shaft 22. In a second position, the bias imposed by return spring 38is overcome and engaging surface of the cam 50 engages the rod 19 suchthat the blunt dissection tip 48 is extended outwardly from the shaft22. The cam 50 is preferably provided with an actuator portion 58 whichextends radially outwardly and which may be used by the operator forrotating the cam.

[0179] Alternatively, other means such as pneumatic force generatingmeans, hydraulic force generating means, piezoelectric force generatingmeans, and electric force generating means may be used to overcome thebias of the spring and extend the blunt dissection tip 48.

[0180] It is preferred that this instrument be manufactured from asterilizable material having sufficient rigidity for its intendedpurpose. Many acceptable materials are well known in the art, such asstainless steel for the shaft 22, and stainless steel or a plastic forthe handle portion 12.

[0181] Alternatively, the guide member placement device may be made in adisposable form. In this embodiment, the components preferably are madeof a suitable thermoplastic. In particular, the thermoplastic Cycolac2679F made by General Electric Plastics has been found suitable, whichis Acrylonitrile Butadiene Styrene (ABS). Preferably, the shaft 22,blunt dissector 32, and return spring 38 are made of stainless steel.

[0182] The use of the guide member placement devices of FIGS. 1-7D in arepresentative bladder neck stabilization procedure employing a sling isdescribed below and depicted in FIGS. 8-14. However, those skilled inthe art will appreciate that the guide member placement device may alsobe used in a number of other surgical procedures requiring introductionof a guide member.

[0183] The following procedure is intended to place a guide member inthe tissue between the urethra and the vaginal wall without puncturingthe vaginal wall. A Foley catheter is placed in the bladder to identifythe bladder neck. The guide member placement device is percutaneouslyinserted into the body. For example, a pair of approximately one inchsuprapubic incisions 60 and 61, shown schematically in FIG. 9, may bemade over the pubic tubercles and dissection may be carried down to thearea of the rectus fascia. A first guide member placement device 10 isplaced within one of the incisions and advanced along the back side ofthe pubic bone so that the distal tip of the shaft 22 is in contact withthe bone/fascial surface to decrease the risk of puncturing the bladder.As resistance is felt, the cam 50 is pressed to extend the bluntdissection tip 48 from the distal end of the shaft 22, thereby creatingan opening in the body tissue 62 as shown in FIGS. 8 and 11. The cam 50is then released, retracting the blunt dissection tip 48 into the shaft22, and the device 10 is advanced through the opening in the bodytissue. This process results in the creation of a first opening in thebody tissue.

[0184] The first guide member placement device 10 is advanced until itis positioned under the urethra 64 within the tissue 62 lying betweenthe urethra 64 and the upper vaginal wall 66 as shown in FIG. 9. Theblunt dissection tip 48 is extended and retracted during advancement ofthe guide member placement device 10 so as to create an opening in thetissue. Advancement of the guide member placement 10 device withextension and retraction of the blunt dissection tip 48 is continueduntil the distal end of the shaft 22 is positioned approximately midlineto the urethra 64 as shown in FIG. 10 such that the distal end of theshaft 22 extends transversely between the urethra 64 and the uppervaginal wall 66 in the plane defined by the longitudinal axes of theurethra and the vagina.

[0185] Alternatively, a pocket or opening in the tissue between theurethra and the vagina may be created beneath the bladder neck prior toinsertion of the first guide member placement device using the devicesand methods described below. In this embodiment, the first guide memberplacement device 10 is advanced such that the distal end of the shaft isin the pocket or opening and the device is positioned as describedabove.

[0186] As the guide member placement device 10 is advanced, the elasticupper vaginal wall tents. This tenting can be utilized to determine theposition of the guide member placement device 10. The guide memberplacement device is advanced until tenting is apparent at the desiredlocation.

[0187] The above process is repeated with a second guide memberplacement device 1910 as shown in FIG. 12. The second guide memberplacement device 1910 has an engaging member 1928 complementary to thatof the first guide member placement device 10 as shown in FIG. 6. Theblunt dissection tip 1948 of the second guide member placement device1910 is extended and retracted to create a second opening in the bodytissue as described above and shown in FIG. 11.

[0188] The second guide member placement device 1910 is advanced to aposition approximately midline to the urethra 64 such that the distalend of the shaft 1922 extends transversely between the urethra 64 andthe upper vaginal wall 66 in the plane defmed by the longitudinal axesof the urethra and the vagina.

[0189] Alternatively, in the embodiment in which the pocket or openingin the tissue between the urethra and the vagina is created prior toinsertion of the first guide member placement device, the second guidemember placement device is advanced into the pocket or opening.

[0190] The second guide member placement device 1910 is then alignedwith the first guide member placement device 10.

[0191] The first and second guide member placement devices 10 and 1910are then joined through their engaging members 28, 1928, creating acontinuous opening in the tissue 62 between the urethra 64 and the uppervaginal wall 66, as shown in FIG. 13. In an alternative embodiment, inaddition to joining the two shafts, the two handles may also be coupledtogether and secured to one another.

[0192] After joining of the two guide member placement devices 10, 1910,the lumens 42, 1942 of the blunt dissectors are in fluid communicationwith one another, as shown in FIG. 6. As shown in FIGS. 13 and 2, aguide member 68 is then inserted into the lumen 18 in the handle 12 ofthe first guide member placement device 10 and advanced through thelumens 40, 1940, 42, 1942 of the blunt dissectors of the first andsecond guide member placement devices 10, 1910 until it exits from thehandle 1912 of the second guide member placement device.

[0193] The engaging members 28, 1928 of the two guide member placementdevices 10, 1910 are then disengaged from one another and the devices10, 1910 are removed from the patient's body, leaving the guide member68 in place, as shown in FIG. 14.

[0194] The guide member 68 may then be used to introduce a slingattached to a sling application catheter in order to stabilize thebladder neck or stabilize the urethral floor as described in thefollowing sections.

[0195] In alternative embodiments of the method, rather than using theblunt dissection tips 48 of the guide member placement devices to createthe continuous opening in the tissue, the guide member placement devicemay be inserted to a pre-formed opening in the tissue between theurethra and the upper vaginal wall. The pre-formed opening may becreated by hydrodissection or with balloon catheters as described below.The steps of this embodiment of the method are similar or identical tothe method described above. However, if desired, this embodiment of themethod can be practiced with guide member placement devices having ablunt dissector which is fixed in a position in which it is extendedfrom the shaft.

[0196] In an alternative embodiment of the method, the guide memberplacement device may be advanced through a trocar into the tissuebetween the urethra and the upper vaginal wall. In another embodiment,the guide member placement device may be viewed laparoscopically duringthe procedure to ensure proper positioning and assist in the alignmentof the first and second guide member placement devices.

Sling Application Catheter

[0197] Another aspect of the present invention is a sling applicationcatheter for introducing a sling into an opening or pocket in thepatient's body tissue. In particular, the sling application catheter ofthe present invention can be used in urethral floor reconstructionprocedures, such as bladder neck stabilization procedures, to introducea sling into the tissue between the urethra and the upper vaginal wallin a less invasive manner than the techniques currently in use.

[0198] Generally, the sling application catheter comprises a catheterhaving a sling therein which is releasably engaged with the catheter.Preferably, the sling is releasably engaged by a pouch in the catheter.Preferably, the sling application catheter is adapted to be guided alonga guide member. The guide member may be a suture, guidewire, or otherstructure suitable for guiding the sling application catheter to adesired location.

[0199] The sling application catheter may be attached to the guidemember, suture, or other guiding device in numerous ways. For example,the catheter may have a lumen extending therethrough through which theguide member passes. The guide member may pass along the full length ofthe lumen, thereby extending entirely through the catheter.Alternatively, the guide member may extend partially through the lumenbut exit the catheter along its length through an opening in the wall ofthe catheter.

[0200] In yet another embodiment, a loop with an aperture therein may beattached to the catheter. In this embodiment, the guide member passesthrough the loop to guide the catheter along the length of the guidemember. Those skilled in the art will appreciate that there are avariety of other ways to permit the sling application catheter to travelalong the guide member, and the present invention contemplates suchadditional approaches.

[0201] Preferably, the sling application catheter is long enough to spanbetween an insertion site in the patient's body and an exit site in thepatient's body. The insertion site and exit site are positioned oneither side of the location to which the sling is to be delivered.

[0202] The catheter may be a continuous cylinder with a lumen extendingtherethrough. Alternatively, the surface of the catheter may bepartially open with a slot therein which is narrower than the width ofthe guide member, suture or other guiding device. Preferably, the distalend of the catheter has a tapered tip to facilitate its passage throughthe body tissue.

[0203] The pouch permits the sling to be handled without damage,maintains a barrier preventing microorganisms from contacting the sling,provides handling flexibility, and ensures that the sling is introducedinto the opening or pocket in the patient's body tissue in the desiredorientation. The pouch may be made of a variety of materials such aspolyethylene terephthalate (PET), polyethylene (PE), vinyl, polyesterand ethylene vinyl acetate (EVA). Preferably, the pouch is made of PET.

[0204] Preferably, the pouch is flat to facilitate delivery of the slingin a flat orientation. However, the pouch may also be conical, or rolledconical, and be provided with means for flattening the sling afterdelivery. Alternatively, the sling application catheter may be used inconjunction with slings made from materials which adopt a flatconfiguration after delivery.

[0205] Preferably, the pouch is clear or translucent to permitvisualization of the sling within. In some embodiments, the pouch ismade of a porous material such as polyethylene, polyethyleneterephthalate or vinyl. In one embodiment, the pouch is adapted toreceive a sling long enough to pass between a first suprapubic incisionon one side of the urethra and a second suprapubic incision on theopposite side of the urethra.

[0206] In an alternative embodiment, the pouch may be adapted to receivea sling having a shorter length than the slings used with the embodimentdescribed above. Such slings are attached to the pubic bone by sutures.

[0207] Long and short slings suitable for use with the present inventionare described in the copending U.S. Patent Application entitled“Stabilization Sling for Use in Minimally Invasive Pelvic Surgery”(VESITEC.023A), filed simultaneously herewith, and the identicallytitled U.S. Provisional Patent Application Serial No. 60/038,379, filedFeb. 13, 1997, the disclosures of which are incorporated herein byreference.

[0208] The length of the pouch may be varied depending upon the lengthof the sling with which the sling application catheter is to be used.

[0209] One embodiment of a sling application catheter 210 according tothe present invention is shown in FIGS. 15 and 16. The sling applicationcatheter of FIG. 15 comprises a catheter 212 and a pouch 214 adapted toreleasably engage a sling 216 attached thereto. The distal end 218 ofthe catheter is tapered and extends beyond the distal end 220 of thepouch. The distal end 220 of the pouch is also tapered to facilitate itspassage through the patient's body tissue. A lumen 222 extends throughthe catheter.

[0210] A cross section of the sling application catheter 210 of FIG. 15with a sling 216 inside the pouch 214 is shown in FIG. 17. The sling 216depicted in FIG. 15 is sufficiently long to pass between two suprapubicincisions on opposite sides of the urethra. Preferably, the sling 216extends beyond the proximal end 224 of the pouch of the slingapplication catheter to permit the proximal end 226 of the sling to begrasped or secured.

[0211] Alternatively, shorter slings which are attached to the pubicbone via sutures may be used. The sling 216 may have sutures or integralattachment members extending bilaterally therefrom. Long and shortslings suitable for use with the present invention are disclosed in thecopending U.S. Patent Application entitled “Stabilization Sling for Usein Minimally Invasive Pelvic Surgery” (VESITEC.023A), filedsimultaneously herewith, and the identically titled U.S. ProvisionalPatent Application Serial No. 60/038,379, filed Feb. 13, 1997, thedisclosures of which are incorporated herein by reference. In such anarrangement, a suture or integral attachment member extends beyond theproximal end 224 of the pouch and can be grasped or secured by thephysician to withdraw the sling from the pouch.

[0212] As illustrated in FIGS. 18 and 19, in alternative embodiments ofthe sling application catheter 310, the pouch 314 has a reinforcingstiffener 328. The reinforcing stiffener 328 may be on the interior orthe exterior of the pouch 314. The stiffener 328 provides rigidity andprevents distortion of the sling 316 during passage through thepatient's body tissue, as well as permitting the sling applicationcatheter 310 to dilate or tear an opening in the patient's body tissueas it passes therethrough. In this manner, the sling applicationcatheter 310 may be used to create an opening in the tissue between theurethra and the upper vaginal wall in which the sling is introduced. Thestiffener 328 may also provide a bending effect which permits the slingto follow an axial bend along its width. Finally, the stiffener 328reduces damage to the sling material during handling.

[0213] The stiffener 328 may be made of any of a variety of materialscompatible with the above described considerations such as polyethylene,polypropylene, or acrylic. Preferably, the stiffener 328 providesapproximately a 1 cm radius of bending.

[0214] In some embodiments, the stiffener 328 is made of a porousmaterial such as polyethylene or polyethylene terephthalate having poreswhich permit a solution to access the sling during a soak as describedbelow.

[0215] Preferably, the sling 216 introduced into the opening in thepatient's body is sterile. In this regard, FIG. 20 depicts a furtherembodiment of the sling application catheter 410, in which the pouch 414has pores 411 to permit rehydration of slings made of natural materialsand antibiotic or saline soaks of the sling in the pouch prior tointroduction of the sling into the patient. In this embodiment, thepouch 414 may be made of a variety of materials, such as PE, PET orvinyl. Preferably, the porous material has pore sizes ranging from about100 microns to about 0.25 inches. Preferably, the pouch 414 is made ofvinyl having a pore size of 0.125 inches.

[0216] The sling application catheters described above may be used in avariety of procedures in which delivery of a sling to an opening orpocket in the patient's body tissue is desired. A representative methodin which the sling application catheter of FIGS. 15-20 are used todeliver a sling in a bladder neck stabilization procedure is describedbelow and depicted in FIGS. 21-23. While the procedure is described withparticular reference to the sling application catheter 210 of FIG. 15,those skilled in the art will appreciate that the sling applicationcatheters 310, 410 of FIGS. 18 and 20 may also be used in the procedure.

[0217] A guide member 68 is introduced into the tissue between theurethra and the upper vaginal wall using a device such as the guidemember placement devices 10, 1910 described above. As illustrated inFIG. 21, the guide member extends between two suprapubic incisions 61and 62 on opposite sides of the urethra 64. As shown in FIG. 21, the endof the guide member 68 extending from the first suprapubic incision 60in the patient's body is inserted into the lumen 222 of the catheter 212such that the guide member passes 68 entirely through the catheter 212.A sling 216 capable of passing beneath the urethra and through theabdominal tissue on opposite sides of the urethra 64 is inserted intothe pouch 214 such that the proximal end 226 of the sling extends fromthe proximal end 224 of the pouch.

[0218] Alternatively, a shorter sling 216 may be used. Such shorterslings may be attached to the pubic bone by sutures. In this embodiment,the sling may have sutures or integral attachment members extendingbilaterally and may be inserted into the pouch so that a suture orintegral attachment member extends from the proximal end of the pouch.

[0219] Long and short slings suitable for use with the sling applicationcatheter are described in the copending U.S. Patent Application entitled“Stabilization Sling for Use in Minimally Invasive Pelvic Surgery”(VESITEC.023A), filed simultaneously herewith, and the identicallytitled U.S. Provisional Patent Application Serial No. 60/038,379, filedFeb. 13, 1997, the disclosures of which are incorporated herein byreference.

[0220] The physician percutaneously inserts the sling applicationcatheter and advances it along the guide member. For example, the slingapplication catheter may be inserted through a first suprapubic incision60. As the pouch 214 passes beneath the urethra 64, the physician graspsthe portion of the sling or the suture or integral attachment memberextending from the proximal end of the pouch while continuing to advancethe sling application catheter 210, causing the sling 216 to bewithdrawn from the pouch 214 as illustrated in FIG. 22. The slingapplication catheter is advanced until it exits the patient's body at asecond suprapubic incision 61, leaving the sling extending between thefirst 60 and second 61 incisions as shown in FIG. 23.

[0221] Alternatively, when the shorter slings are used, the sutures orintegral attachment members extend from the first and second incisions.

[0222] Following the completion of the preceding procedures, the sling216 is located in the tissue 62 between the urethra and the uppervaginal wall.

[0223] Following implantation, the sling or sutures or integralattachment members extending therefrom may be sewn, stapled, riveted, oranchored to any of a variety of structures, such as the pubic bone,Cooper's ligament or rectus fascia to stabilize or stabilize the bladderneck or to stabilize the pelvic floor. For example, the long sling maybe attached directly to the pubic periosteum using staples, clips, orsutures or may be attached to the pubic bone with short sutures attachedto a bone anchor implanted in the pubic bone or fastened to the pubicbone with a headed nail or screw-like anchoring device.

[0224] The slings may be used to stabilize the bladder neck as describedin the copending U.S. Patent Application entitled “Stabilization Slingfor Use in Minimally Invasive Pelvic Surgery” (VESITEC.023A), filedsimultaneously herewith, and the identically titled U.S. ProvisionalPatent Application Serial No. 60/038,379, filed Feb. 13, 1997. Thetension on the sling may be adjusted as appropriate, using approachessuch as those described in U.S. Pat. No. 5,611,515, issued Mar. 18, 1997to Benderev et al., the disclosure of which is incorporated herein byreference, to support the bladder neck or stabilize the urethral floor,thereby maintaining or improving urinary continence.

Tissue Dissector/Dilator

[0225] Another aspect of the present invention is a tissuedissector/dilator 510 for creating an opening or pocket in a body tissueand dilating the opening or pocket with an expandable dilator. Thetissue dissector/dilator finds particular application in urethral floorreconstruction procedures, such as bladder neck stabilization proceduresin which the tissue between the female urethra and the upper vaginalwall is dissected and dilated to facilitate placement of a therapeuticsling device designed to alleviate incontinence.

[0226] The tissue dissector/dilator can be used in percutaneousapproaches in which the sling is introduced into an opening or pocket inthe tissue between the urethra and the upper vaginal wall without entryof the vaginal canal. Such procedures are described in detail below.

[0227] The tissue dissector/dilator generally comprises a body with anon-compliant shaft attached thereto. Preferably, the shaft has at leastone lumen extending therethrough.

[0228] A dissector for creating an opening or pocket in the body tissueis carried on the shaft. The dissector may be on the exterior of theshaft or in the interior. Preferably, the dissector is within the lumenof the shaft and is axially movable such that it is capable of beingextended from and retracted in the shaft to create an opening in thebody tissue.

[0229] A dilator for dilating the opening or pocket is also carried onthe shaft. The dilator may be on the exterior of the shaft or in theinterior. Preferably, the dilator is within the lumen of the shaft andis axially movable such that it is capable of being extended from andretracted in the shaft. Preferably, the dilator is expandable andcollapsible.

[0230] Preferably, the dissector and the dilator are integral.Alternatively, the movable dissector and the dilator can be separateelements of the tissue dissector/dilator. Preferably, both the dissectorand the dilator are axially movable.

[0231] In yet another embodiment, the dissector and the dilator are notintegral parts of the tissue dissector/dilator. In this embodiment, thedissector and the dilator are distinct devices which can be insertedinto the shaft of the tissue dissector/dilator at the point in thesurgical procedure in which tissue dissection or dilation is required.

[0232] A representative embodiment of the tissue dissector/dilator 510is shown in FIG. 24. As shown in FIG. 24 the body 512 comprises atrigger 514, a locking wheel 516, and a spring return button 518. In theembodiment of FIG. 24, the trigger 514 and the upper section 520 of thebody each have a slot 522 and 524 therein which together defme anaperture 526 adapted to receive a syringe 528 therein. However, thoseskilled in the art will appreciate that the body 512 can have a numberof configurations compatible with the intended use of the tissuedissector/dilator and the present invention encompasses such additionalconfigurations.

[0233] The spring return button 518 can slide along a slot in a verticalface of the body. As shown in FIG. 24, the spring return button 518 isbiased towards a first position at the proximal end of the slot by aspring. As shown in FIG. 25, the spring return button 518 can slide to asecond position in which it is locked in place. As illustrated in FIG.25, in the locked position, the spring return button 518 fits into agroove on the body 512 and is located on a face of the bodyperpendicular to the face on which the spring return button 518 islocated in the unlocked state.

[0234] The spring return button 518 may have an internal extensioninside the body which has a proximal section adapted to receive asyringe tip.

[0235] As illustrated in FIG. 24, the shaft 530 is attached to thebottom portion 532 of the body 512 and has a lumen extendingtherethrough. The shaft 530 may be fabricated from a number ofnon-compliant materials sturdy enough to resist torque applied while thedevice is advanced through the body tissue. Preferably the shaft 530 ismade of stainless steel.

[0236] Preferably, the shaft 530 curves towards its distal end 534.Preferably, the curve is a small radius curve. Preferably, the distalend 534 of the shaft is at an angle of about 90° relative to theproximal portion of the shaft. However, those skilled in the art willappreciate that the curve in the shaft 530 may vary depending onanatomical considerations and the type of procedure in which the tissuedissector/dilator is to be used.

[0237] As shown in FIG. 25, a balloon catheter 536 is located within thelumen of the shaft 530 and is engaged by the spring return button 518.As illustrated in FIG. 5 26, the balloon catheter 536 comprises an outertube 538 having a lumen extending therethrough and an expandable balloon540 in the lumen of the outer tube 538. An inflation tube 542 with alumen therein is located at the proximal end 544 of the expandableballoon and is in fluid communication with the interior of the balloon540. Preferably, the expandable balloon 540 has a blunt dissection tip546 at its distal end 548.

[0238] The inflation tube 542 may be made of any of a number ofmaterials, such as PE or PET. Preferably, the inflation tube 542 is madeof a non-compliant or minimally compliant material.

[0239] In the embodiment of FIG. 26, the expandable balloon 540 has acylindrical shape when expanded. Preferably, the dimensions of theballoon are adapted for dilating an opening or pocket in the tissuebetween the urethra and the upper vaginal wall. The length of theballoon is dependent upon the direction in which it is oriented relativeto the urethra in the procedure being used to create the pocket oropening. When the balloon is oriented perpendicular to the urethra theballoon is preferably 4-6 cm in length, with an effective width of 2 cmto create a pocket or opening of approximately 5 cm in length and 2 cmin width.

[0240] When used in procedures in which the balloon is oriented parallelto the urethra the balloon may be shorter than those used in proceduresin which the balloon is perpendicular to the urethra. Balloons used insuch procedures may also have a larger diameter than those used inprocedures in which the balloon is perpendicular to the urethra. Ballooncatheters having a plurality of balloons side by side or flat profileballoons, such as those described in more detail below, are also wellsuited for such procedures.

[0241] Preferably, the balloon expands radially but does not increase inlength when expanded.

[0242] The blunt dissection tip 546 is preferably cylindrical in shape.Preferably, the blunt dissection tip 546 is about ¼ inch in length.

[0243] The blunt dissection tip 546 may be fabricated from a variety ofmaterials which are rigid enough to facilitate their use in bluntdissection of a body tissue. The tip of the balloon may be formed into asolid tip which functions as the blunt dissection tip. Alternatively,the blunt dissection tip 546 may comprise the same material as theinflation tube 542. In yet another embodiment, the blunt dissection tipmay be stainless steel.

[0244] The balloon catheter may also have a second lumen therein forreceiving a guide member. In this embodiment, a guide member may beplaced through the aperture in the body, pass through the shaft, andextend out of the distal tip of the shaft, permitting the tissuedissector/dilator to be used to place a guide member in the opening orpocket created in the body tissue. The guide member may be a suture,guidewire, or other structure suitable for guiding a sling to a desiredlocation.

[0245] In another embodiment, the balloon catheter may have a thirdlumen therein for irrigation or for receiving diagnostics, such as anultrasound catheter. The third lumen may also be used for passage of animplant, such as fibrin glue or a bladder neck suspension orstabilization sling, such as those described in the copending U.S.Patent Application entitled “Stabilization Sling for Use in MinimallyInvasive Pelvic Surgery” (VESITEC.023A), filed simultaneously herewith,and the identically titled U.S. Provisional Patent Application SerialNo. 60/038,379, filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference.

[0246] As shown in FIG. 24, when the spring return button 518 ispositioned at the most proximal point of its path in the vertical faceof the body 512, the balloon catheter 536, including the blunt tip 546and the expandable balloon 540, is retracted within inside the shaft530. As illustrated in FIG. 27, when the spring return button 518 ismoved towards the distal end of the slot, force is communicated to theballoon catheter 536 causing it to move axially towards the distal end534 of the shaft, such that the blunt dissection tip 546 extends out ofthe shaft 530. If the spring return button 518 is then released, thebias from the spring will cause the spring return button 518 to returnto the most proximal point of the slot, thereby returning the bluntdissection tip 546 to a fully retracted position within the shaft 530.Preferably, the spring return button 518 provides a one to one strokemotion to the blunt dissection tip 546. When the spring return button518 is locked at its most distal position, the expandable balloon 540and the blunt dissection tip 546 protrude from the distal end 534 of theshaft, as shown in FIG. 25.

[0247] As shown in FIG. 24, the proximal end of the body is adapted toreceive a syringe 528 therein. The syringe 528 comprises a plunger 550,a reservoir, and a tip. The tip of the syringe engages the proximalsection of an internal extension of the spring return button 518. Asillustrated in FIG. 25, when the spring return button 518 is placed inthe locked position, the syringe 528 moves into the body 512 and ispositioned so as to permit the plunger 550 to engage the trigger 514.The tip of the syringe contacts the locking wheel 516 and engages a luerconnection thereon. When the locking wheel 516 is tightened, the syringe528 is firmly fixed in place such that the reservoir of the syringe isin fluid communication with the lumen of the balloon catheter.

[0248] With the spring return button 518 in the locked position, theplunger 550 of the syringe engages the trigger 514, such that squeezingthe trigger 514 causes the plunger 550 of the syringe to be depressed.When the reservoir of the syringe is filled with a fluid, such assterile saline or sterile water, squeezing the trigger 514 causes thefluid to be dispensed from the syringe 528 into the lumen of theinflation tube 542, thereby inflating the expandable balloon asillustrated in FIG. 28. The trigger 514 contains a return spring, suchthat when the trigger 514 is released from the squeezed position, thetrigger returns to its original position, drawing the plunger 550 of thesyringe upward and thereby creating a vacuum in the syringe reservoirwhich draws the fluid from the expandable balloon 540 and deflates theballoon. The plunger 550 and the trigger 514 may be interconnectedthrough a variety of structures familiar to those skilled in the art.For example, they may be interconnected through a rack and pinion gear.

[0249] An alternative embodiment of the tissue dissector/dilator 610 isshown in FIG. 29. In this device, the trigger 654 has an alternate shapeas shown in FIG. 29 and engages a set of teeth 652 on the plunger 650 ofthe syringe. The body has a central aperture 626 therein which receivesthe syringe. Additionally, in this embodiment the locked position of thespring return button 618 is close to the bottom of the body 612 and thespring return button 618 is on the same face of the body in its lockedand unlocked states.

[0250] While several embodiments of the tissue dissector/dilator havebeen described above, those skilled in the art will appreciate thatalternative configurations are compatible with the function of thedevice. Such additional configurations are within the scope of thisinvention.

[0251] The following section describes the use of the tissuedissector/dilator in the context of a percutaneous bladder neckstabilization or suspension procedure in which a sling is utilized fortreating urinary incontinence in females. However, those skilled in theart will recognize that the tissue dissector/dilator may also findapplication in a variety of other procedures in which it is necessary tointroduce an opening into a body tissue and subsequently dilate thatopening. While the procedure is described with particular reference tothe tissue dissector/dilator 510 shown in FIGS. 24, 25, 27 and 28, thoseskilled in the art will appreciate that the tissue dissector/dilator 610shown in FIG. 29 may also be used in the procedure.

[0252] The shaft of the tissue dissector/dilator is insertedpercutaneously. For example, percutaneous insertion may be through a oneinch transverse incision made over a pubic tubercle with dissection iscarried down to the area of the rectus fascia The tissuedissector/dilator 510, 610 is guided through the patient's body tissuealong the back side of the pubic bone while maintaining the distal endof the shaft in contact with the pubic bone. If resistance isencountered while advancing the tissue dissector/dilator through tissue,the spring return button 518 may be repetitively partially depressed andallowed to return to its most proximal position through the action ofthe biasing spring. This process results in repetitive extension of theblunt dissection tip 546 out of the shaft 530 and retraction of theblunt dissection tip 546 back into the shaft 530, thereby dissecting anopening in the body tissue through which the device is passing.

[0253] The tissue dissector/dilator 510 is advanced until tenting isobserved on the upper vaginal wall. As shown in FIG. 30, the user thenmanipulates the distal end of the shaft 534 until it intersects thetissue 62 between the urethra 64 and the upper vaginal wall 66 atapproximately mid-thickness and in a direction which would permit theexpandable balloon to advance perpendicular to the axial direction ofthe urethra.

[0254] As illustrated in FIG. 31, the tissue 62 between the urethra 64and the upper vaginal wall 66 is then blunt dissected by repetitivelyextending and retracting the blunt dissection tip 546 using the springreturn button 518 as described above, thereby creating an opening in thetissue. The dissection process is repeated until an opening is createdin the tissue 62 which is large enough to permit the expandable balloon540 to be fully extended from the shaft 530 such that the distal end ofthe shaft extends transversely between the urethra 64 and the uppervaginal wall 66 in the plane defined by the longitudinal axes of theurethra and the vagina, as shown in FIG. 32.

[0255] The spring return button 518 is advanced to its locked positionin which the expandable balloon 540 is fully extended into the openingin the body tissue, as shown in FIG. 32. The syringe 528 is locked inplace such that its reservoir is in fluid communication with the lumenof the inflation tube 542 of the balloon catheter 536 and its plunger550 engages the trigger 514. The trigger 514 is squeezed to dispense thesaline solution inside the reservoir of the syringe through theinflation tube 542 of the balloon catheter 536 and into the expandableballoon 540, causing the balloon 540 to expand. Expansion of the balloon540 dilates the body tissue, creating a first opening therein as shownin FIG. 33.

[0256] The trigger 514 is then released and is returned to its originalposition through the action of the return spring. As the trigger returnsto its original position, a vacuum is created in the reservoir of thesyringe 528, thereby drawing the fluid out of the expandable balloon 540and causing the balloon 540 to deflate.

[0257] The trigger 514 can be squeezed and released multiple times, ifnecessary, until the opening in the body tissue expands. The expandableballoon 540 and blunt dissection tip 546 are then retracted into theshaft 530.

[0258] The above dissection and expansion steps can be repeated whileadvancing the tissue dissector/dilator through the tissue between theurethra and the upper vaginal wall, as shown in FIGS. 34-36. Thedissection and expansion steps may be repeated until a continuousdilated opening or pocket 11 exists in the tissue 62, as shown in FIG.37. Following the creation of the continuous dilated opening or pocket,the tissue dissector/dilator is removed from the patient's body.

[0259] Alternatively, the continuous dilated opening or pocket 11 can becreated from both sides of the urethra. In this procedure, a firsttissue dissector/dilator is advanced approximately to the midline of theurethra while dissecting and expanding the tissue 62 as described aboveto create a first opening in the body tissue. The first tissuedissector/dilator may be removed from the body, or, in the embodimentsdescribed below in which two tissue dissector/dilators areinterconnected to pass a guide member or suture through the patient'sbody, the first tissue dissector/dilator may remain in the patient'sbody.

[0260] A second tissue dissector is percutaneously inserted. This may beaccomplished through a second suprapubic incision made on the oppositeside of the urethra from the first suprapubic incision. A second tissuedissector/dilator 510 is inserted into the second incision and advancedthrough the body tissue until it is aligned with the first opening inthe body tissue. Correct alignment of the second tissuedissector/dilator with the first opening in the body tissue isdetermined through visualization of tenting of the vaginal wall andthrough tactile sensation. The blunt dissector tip 546 of the secondtissue dissector/dilator 510 is extended and retracted from the shaft530, thereby creating a second opening in the body tissue which isjoined to the first opening in the body tissue. The expandable balloon540 is extended into the second opening and expanded within the secondopening, thereby dilating the body tissue. When the second tissuedissector/dilator 510 is removed from the patient's body a continuousdilated opening or pocket 11 exists in the tissue 62, as shown in FIG.37.

[0261] In both of the above methods, a sling may be introduced into theopening or pocket using the sling application devices described hereinto suspend or stabilize the pelvic floor.

[0262] In the embodiment in which the balloon catheter has a secondlumen for receiving a guide member, the tissue dissector/dilator may beused to introduce a guide member as follows. After creation of the firstopening or pocket but before removal of the first tissuedissector/dilator from the body, a guide member, suture, guide catheter,or webbing is introduced into the second lumen of the catheter. When thefirst tissue dissector/dilator is removed from the body, the guidemember is left in place.

[0263] After creation of the continuous pocket but before removal of thesecond tissue dissector/dilator from the body, the guide member in thefirst pocket is introduced into the second lumen of the catheter of thesecond tissue dissection/dilator and advanced therethrough. When thesecond tissue dissector/dilator is removed from the body after creationof the continuous pocket, the guide member remains in place and extendsbetween both suprapubic incisions, passing under the urethra and throughthe continuous pocket. Alternatively, the tissue dissector/dilator mayhave an engaging member at the distal end of the shaft, permitting twodevices to be interconnected with their lumens in fluid communication asdescribed above for the guide member placement device. In thisembodiment, the guide member, suture, guide catheter, or webbing ispassed through the interconnected lumens of the first and second tissuedissector/dilators as described above in regard to the guide memberplacement device. Thus the guide member, suture, guide catheter orwebbing extends between the two suprapubic incisions and passes throughthe tissue between the urethra and the upper vaginal wall.

[0264] The guide member can then be used to introduce a sling into theopening or pocket as described above.

[0265] In yet another embodiment, the tissue dissector/dilator may beused in transvaginal procedures. For example, the tissuedissector/dilator may be inserted through the upper vaginal wall ratherthan through suprapubic incisions. In this embodiment the device isadvanced into the tissue 62 between the urethra and the upper vaginalwall and the balloon is expanded to create an opening or pocket asdescribed above.

Sling Application Device and Sling Application System

[0266] Another aspect of the present invention is a sling applicationdevice for inserting a sling into an opening or pocket in a body tissue.The sling application device provides access to the tissue between theurethra and the upper vaginal wall and introduces a sling into a pocketor opening in that tissue. In some embodiments, the sling applicationdevice creates the pocket or opening into which the sling is inserted.In other embodiments, the sling application device introduces the slinginto a pre-formed pocket or opening. The device may be used inpercutaneous methods alone or in laparoscopic procedures.

[0267] Another sling application device for introducing a sling into thetissue between the urethra and the upper vaginal wall is currentlyavailable . This device comprises two shafts, each having a centrallumen, which can be clamped together via horizontally extending tabspresent at the proximal end of each shaft. Rotation of a lever on one ofthe horizontal tabs clamps the two tabs together, thereby locking thetwo shafts to one another.

[0268] The currently available device is used to introduce a sling intothe tissue between the urethra and the upper vaginal wall as follows.The two shafts are introduced into incisions on opposite sides of theurethra in the unlocked configuration. The shafts are advanced throughthe patient's tissue until they are located underneath the urethra withthe lumens of the two shafts aligned. The lever is then rotated to thelocked position, fixing the two shafts together. A sharp blade isinserted through the lumen of one of the two shafts such that itcontacts the tissue between the distal ends of the shafts. As the bladeis advanced through the tissue between the distal ends of the shafts,the tissue is dissected. Eventually, the blade enters the lumen of thesecond shaft, thereby creating a continuous opening in the tissuebetween the urethra and the upper vaginal wall.

[0269] The two shafts are unlocked and one of them is removed from thepatient's body. A suture is inserted into the eye of the blade and theblade is advanced into the opening in the tissue between the urethra andthe upper vaginal wall. A right angle clamp is then used to grasp andfollow the suture into the tissue between the urethra and the uppervaginal wall. When the jaws of the right angle clamp are spread, anenlarged opening sized to receive a sling is created. The sling is thenguided along the suture and introduced into the enlarged opening.

[0270] As will be apparent from the following description, the presentsling application device provides several advantages over the currentlyavailable device. For example, the present device eliminates the use ofa right angle clamp to create the sling receiving opening which isrequired with the currently available device. Moreover, the slingintroducer permits the sling application device to introduce the slingwithout the use of a guiding suture as required with the currentlyavailable device. A further advantage of the present device and methodsfor using the device is that when the pocket or opening is created byhydrodissection the procedure can be performed without cutting thetissue between the two shafts of the sling application device.Furthermore, with the present device, it is not necessary to seat thedistal ends of the shaft together before locking the two halves of thedevice to one another.

[0271] The present sling application device generally comprises a firstand a second shaft. The first and second shafts have a central lumenwhich is sized to allow a sling to advance therethrough. The lumens ofthe first and second shafts may also be sized to allow a slingintroducer to pass therethrough. Preferably, the shafts of the presentsling application device are sufficiently wide to create or maintain anopening in the tissue capable of receiving the sling.

[0272] Preferably, the sling application device further comprises afirst handle attached to the first shaft and a second handle attached tothe second shaft. The first and second handles have openings thereinwhich are in fluid communication with the lumens in the shafts to whichthe handles are attached. Preferably, the first and second handles areadapted to be connected to one another.

[0273] The present sling application device includes an adjuster forincrementally adjusting the distance between the distal ends of thefirst and second shafts. The adjuster allows the distance between thedistal ends of the shafts to be slowly decreased while monitoring thepatient to ensure that the urethra is not pinched during the procedure.This feature is absent from the currently available device, which hasonly two configurations, the locked and unlocked configurationsdescribed above. Preferably, the adjuster engages the first and secondhandles.

[0274] Preferably, the upper portions of the distal ends of the firstand second shafts are indented relative to the lower portions of thedistal ends to reduce the possibility of pinching of the urethra duringthe sling implantation procedure. This feature is absent from thecurrently available device, increasing the risk of damage to the urethrawhen that device is used.

[0275] The shafts of the present sling application devices are adaptedto receive several components during the sling application proceduresuch that the sling application device can be used as part of a slingintroduction system. The sling introduction system generally comprisesthe sling application device, a blunt dissector and a sling introducer.In some embodiments, the sling introduction system may further comprisea sharp tissue cutter.

[0276] A representative embodiment of the sling application device 710is shown in FIG. 38A. As shown in FIG. 38A, the sling application device710 comprises a first handle 712 and a second handle 714, having first716 and second 718 shafts, respectively, attached thereto. The first andsecond handles have openings 725, 727 and therein which are adapted toreceive a sling or sling introducer. The first and second shafts 716,718 are adapted for insertion into a body tissue and have central lumens711 and 713, respectively, which extend therethrough. The lumens offirst and second shafts are in fluid communication with the openings inthe first and second handles and are adapted to receive a sling or slingintroducer. The first and second shafts 716, 718 have dimensions adaptedfor creating or maintaining a pocket or opening in the body tissue andfor receiving a sling introducer. The sling application device alsocomprises an adjuster 720 for adjusting the distance between the firstshaft 716 and the second shaft 718. Preferably, the adjuster 720 is anarticulating lock.

[0277] As shown in FIG. 38A, the first handle 712 has a generallyrectangular distal portion 722, an indented region 724, and a generallyrectangular proximal portion 726 having a width less than the width ofthe generally rectangular distal portion 722. One face of the firsthandle 712 has a rectangular recess 728 open at each end for receivingan extension 730 on the second handle.

[0278] As shown in FIG. 38B, the first handle has a locking button 732with a tab 717 thereon which is adapted to engage a groove 734 in theextension 730 section which is disposed between the first handle 712 andthe second handle 714, thereby locking the two handles together.Alignment of the first handle 712 with the second handle 714 duringlocking is achieved by placing alignment pin 756 in alignment hole 758.However, those skilled in the art will appreciate that other means foraligning the handles and locking them together may also be used.

[0279] A first shaft 716 with a central lumen therethrough extendsthrough the first handle 712. As shown in FIGS. 39, 40 and 41, the firstshaft 716 is cylindrical and curves toward its distal end 736. The firstshaft 716 may be from about 3 inches to about 10 inches in length, withan outer diameter from about {fraction (3/16)} inch to about ⅝ inch witha wall thickness from about 0.010 inch to about 0.020 inch. Preferably,the first shaft 716 is from about 6 inches to about 8 inches in length,with an outer diameter from about 0.187 inch to about 0.275 inch.However, those skilled in the art will appreciate that the precedingdimensions may vary depending on anatomical considerations and the typeof procedure being performed.

[0280] The first shaft 716 may be made of a variety of materials,including stainless steel and aluminurn. Preferably, the first shaft 716is made from stainless steel.

[0281] The first shaft 716 is curved near its distal end. Preferably,the first shaft 716 curves through an arc from about 80° to about 90°.More preferably, the first shaft 716 curves through an arc of about 90°.

[0282] In an alternate embodiment of the sling application device 810,shown in FIGS. 42, 43 and 44, the portion of the first shaft 816proximal to the curve is cylindrical and the portion of the first shaft816 distal to the curve is a flat tube. The flat tube may have a varietyof cross sectional shapes such as rectangular, hexagonal or oval. Thefirst shaft 816 is curved as described above for the embodiment in whichthe shaft is cylindrical.

[0283] In a further embodiment of the sling application device 910, thefirst shaft 916 comprises a tube which is flat along its entire lengthas shown in FIGS. 45 and 46. The first shaft 916 is curved towards itsdistal end as described above for the embodiment in which the shaft iscylindrical.

[0284] Preferably, the first shaft has a side bend. In accordance withthis embodiment, the first shaft can be flat, cylindrical, or flat insome portions and cylindrical in others as described above with respectto the sling application devices 710, 810, 910 discussed above.

[0285]FIGS. 47, 47A and 47B show a sling application device 1010 inwhich the shafts have a side bend. In this embodiment, the first shaft1016 is flat and has a first curved section 1021 and a second curved1023 section along its length. Preferably, the portion maximum offsetbetween the first curved section 1021 and the second curved section 1023is from about 1 inch to about 3 inches. As shown in FIGS. 47 and 47B,the second shaft 1018 has the same structure as the first shaft 1016.Preferably, the first and second shafts 1016, 1018 undergo a smoothtransition from cylindrical to elliptical or flat. More preferably, theportion of the shaft proximal to the first curved section 1021 iscylindrical and the portion of the shaft distal to the first curvedsection is flat. Preferably, the radius of curvature of the second curveis not planar with the axial plane of the portion of the shaft. Theadjuster 1020 in this embodiment may be the same as the adjusterdescribed above.

[0286] Alternatively, the shaft may have a 90° twist as shown in FIG.48. In this embodiment of the sling application device 1910, theproximal portion 1929 of the first shaft 1916 is oriented at an angle of90° relative to the distal portion 1931 of the first shaft, with atransitional section 1933 disposed between the proximal section of thefirst shaft 1929 and the distal section of the first shaft 1931. Theadjuster 1920 in this embodiment may be the same as the adjusterdescribed above.

[0287] Referring to FIG. 38A, one face 746 of the second handle isadapted to enable the physician to firmly grasp it when advancing thedevice through tissue. An adjuster 720 is slidably mounted on face 746.The adjuster 720 slidably engages a guide 748 on the bottom of the firsthandle 712. The guide 748 is hingedly connected to the extension 730 andis biased away from the extension 730 by a biasing means such as aspring 754 (indicated in FIG. 56) disposed between the guide 748 and theextension 730. Tabs 750 on the adjuster 720 fit into grooves 752 betweenthe sides of the extension 730 and the sides of the guide 748 such thatthe adjuster 720 moves along the guide 748 between a proximal end and adistal end. When the two handles have been locked together, moving theadjuster 720 along the guide 748 adjusts the distance between the distalends of the first and second shafts 716, 718 as depicted in FIGS. 56-58,which are discussed in greater detail below. However, those skilled inthe art will appreciate that there are other adjuster designs compatiblewith the operation of the present device, and such designs arespecifically contemplated in the present invention.

[0288] As the adjuster 720 is moved towards the distal extreme of theguide 748, the resistance of the spring biasing the guide away from theextension 730 is overcome and the distance between the distal ends ofthe first and second shafts 716, 718 decreases. As the adjuster 720 ismoved towards the proximal extreme of the guide 748, the spring pushesthe guide 748 away from the extension 730 and the distance between thedistal ends of the first and second shafts 716, 718 increases.

[0289] The second handle 714 has a second shaft 718 extendingtherethrough. The second shaft 718 may have the same configurations andbe made of the same materials as described above with regard to thefirst shaft 716. Preferably, the second shaft of the second handle hasthe same configuration as the first shaft of the first handle with whichit is to be used, as illustrated in FIGS. 38-48.

[0290] Preferably, as shown in FIG. 49, the upper edges 738 and 740 ofthe distal ends of the first and second shafts 736, 715 are slightlyindented relative to the lower edges 742 and 744 to reduce thepossibility of the urethra being pinched during the sling implantationprocedure.

[0291] A further aspect of the present invention is a blunt dissectorfor dissecting the body tissue without scoring or creasing the tissue orbone with which it comes in contact. The blunt dissector is adapted forinsertion into the first and second shafts of the sling applicationdevice and protrudes from the distal ends of the shafts. The bluntdissector can be used as a component in the sling application system.

[0292] The blunt dissector may be an obturator 1110 as shown in FIG. 50.The obturator comprises an elongate, flat shaft 1112 interposed betweena flexible section 1114 located at the distal end of the shaft and ahandle 1116 located at the proximal end of the shaft 1112. When theobturator 1110 is inserted into the first and second shafts 716 and 718of the sling application device, the flexible section 1114 bends topermit the obturator 1110 to conform to the curves near the distal endsof the shafts 716 and 718. The flexible section 1114 has a generallyrigid tip 1118 at its distal end which extends from the distal ends ofthe first and second shafts 716 and 718 when the obturator 1110 isinserted therein. The generally rigid tip 1118 prevents scoring of thetissue or bone with which it comes in contact when the first and secondshafts 716, 718 are advanced through tissue. In an alternate embodiment,the flexible section may have an opening near its distal end to increaseflexibility.

[0293] The shaft 1112 of the obturator may be made of a variety ofmaterials such as polycarbonate, nylon, polypropylene, and AcrylonitrileButadiene Styrene (ABS). A preferred material is ABS.

[0294] The flexible section 1114 of the obturator may be made of any ofa number of materials, including polycarbonate, nylon, polypropylene,and ABS. Preferably, the flexible section 1114 is made of ABS.

[0295] The generally rigid tip 1118 of the obturator may be made ofmaterials such as polycarbonate, nylon, polypropylene, and ABS.Preferably, the generally rigid tip 1118 is made of ABS.

[0296] When the obturator 1110 is inserted into the first and secondshafts 716, 718, the generally rigid tip of the obturator 1118 protrudesfrom the distal ends of the shafts 716, 718. Preferably, the generallyrigid tip 1118 protrudes a distance of from about 0.1 inch to about 0.25inch from the lower edges 742, 744 of the distal end of the shafts 716,718. More preferably, the generally rigid tip 1118 protrudes a distanceof about 0.20 inch from the lower edges 742, 744 of the distal end ofthe shafts 716, 718.

[0297] Yet another aspect of the present invention is a sling introducer1210 adapted for releasably engaging a sling 1211 and introducing thesling 1211 into the body tissue without the use of sutures. The slingintroducer 1210 can be used as a component in the sling applicationsystem and is adapted for insertion into and advancement through thefirst and second shafts 716, 718 of the sling application device 710.Alternatively, the sling introducer can be used in conjunction withlaparoscopic trocars.

[0298] A representative sling introducer 1210 is shown in FIGS. 51 and52. The sling introducer 1210 can be made of any of a number ofmaterials such as polyethylene, PET or vinyl. Preferably, the slingintroducer 1210 is made of generally rigid vinyl.

[0299] The sling introducer 1210 of FIG. 51 has a narrow elongate distaltip 1212 and a pouch 1214 at the proximal end. The elongate distal tip1212 of the sling introducer of the sling introducer is configured topass through the first and second shafts 716, 178 of the slingapplication device. The sling introducer 1210 is sufficiently long topermit the distal tip 1216 of the sling introducer to protrude from theproximal end of the opening 725 in the first handle of the slingapplication device 710 while the sling 1211 protrudes from the proximalend of the opening 727 in the second handle of the sling applicationdevice 710.

[0300] The pouch 1214 of the sling introducer is sized to receive asling 1211 therein. The slings 1211 introduced with the sling introducer1210 can be long enough to extend between two suprapubic incisions ormay be shorter slings designed to be attached to the pubic bone withsutures. Long and short slings suitable for use with the presentinvention are disclosed in the copending U.S. Patent Applicationentitled “Stabilization Sling for Use in Minimally Invasive PelvicSurgery” (VESITEC.023A), filed simultaneously herewith, and theidentically titled U.S. Provisional Patent Application Serial No.60/038,379, filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference.

[0301] The pouch 1214 is relatively flexible, and is preferably made ofa soft, pliable plastic such as polyethylene, PET or vinyl. In someembodiments, the pouch 1214 may be reinforced by a stiffener to providesome rigidity along the edges as discussed above. The proximal end ofthe pouch 1214 may be sufficiently wide to maintain the sling 1211 in aflat orientation. Alternatively, the pouch of the sling introducer 1210may be rolled up such that the sling is also in a rolled configuration.During introduction of the sling into the opening or pocket in the bodytissue, the sling 1211 may be converted to a flat configuration.

[0302] In one embodiment, the pouch 1214 has pores 1218 therein as shownin FIG. 51 to facilitate re-hydration or soaking treatments of the slingmaterials. In particular, the porous pouch 1214 permits solutions inwhich the pouch is placed to contact the sling inside the pouch. Suchsolutions include saline solutions and antibiotic solutions. In thisway, the pores facilitate treatments in which the sling is soaked inantibiotics to prevent the growth of microorganisms on the surface ofthe sling after the sling 1211 is introduced into the body. The poresalso permit gas sterilization of the sling while it is inside the pouch.

[0303] In this embodiment, the pouch 1214 may be made of a variety ofmaterials, such as PE, PET, or vinyl. Preferably, the pouch is made ofclear material to permit visualization of the sling when it is insidethe pouch. Preferably, the pouch has pore sizes from about 0.10 inch toabout 0.25 inch. Preferably, the pouch 1214 is made of vinyl having apore size of about 0.125 inch.

[0304] In alternate embodiments, the pouch 1214 may be nonporous. Suchpouches may be made of the same materials as described above for theporous pouches. However, the nonporous pouches do not have pores formedtherein.

[0305] Yet another aspect of the present invention is a tissue cutter1310, 1312 for cutting tissue disposed between the distal ends of thefirst shaft and the second shaft. As shown in FIG. 53, the tissue cutter1310 comprises a razor 1312 housed in a razor assembly 1314. A flexiblecatheter 1316 extends from the distal portion of the razor assembly1314. A lumen 1318 extends through the catheter 1316. The width ofcatheter 1316 of the tissue cutter is slightly smaller than the width ofthe second shaft 718 of the sling application device 710, such that thecatheter 1316 can be inserted inside the second shaft 718. The tissuecutter 1310 can be used as a component of the sling application system.

[0306] In the tissue cutter shown in FIG. 53, the razor assembly 1314comprises a handle 1320 having a thumb button 1322 at its proximal endand an elongate catheter 1316 adapted to receive the razor 1312 therein.The thumb button 1322 is movable between a proximal position and adistal position and is biased towards the proximal position by a spring1324 inside the handle. When the thumb button 1322 is depressed, theresistance of the spring 1324 is overcome, and the thumb button 1322engages the razor 1312, moving the razor 1312 to a position in which itprotrudes from the distal end of the catheter 1316. When the thumbbutton 1322 is released, the razor retracts inside the catheter.

[0307] The razor 1312 is slightly smaller in width than the lumen of thecatheter 1316. The width of the razor 1312 is generally the same as thedesired width of the sling 1211 which will be inserted according to theprocedure described below. In addition, as shown in FIG. 53, the razor1312 is slightly tapered at its distal end.

[0308] Although several embodiments of the sling application device andthe components of the sling application system have been describedabove, those skilled in the art will appreciate that otherconfigurations are compatible with the operation of the device and thesystem. For example, a spring biased trigger on the first handle of thesling application device may substitute for the articulating lock foradjusting the distance between the distal ends of the first and secondshafts. Such additional configurations are also contemplated by thepresent invention.

[0309] The sling application device is used as follows. The method isperformed with the patient in the dorsal lithotomy position. In somemethods a pocket or opening 11 is created in the tissue between theurethra and the upper vaginal wall using any of the methods and devicesdisclosed herein. In such methods, the first and second shafts 716 and718 maintain the opening or pocket in a configuration in which the slingcan be introduced.

[0310] Alternatively, the sling application device can be used to createthe opening or pocket 11 in the tissue between the urethra and the uppervaginal wall.

[0311] Both the methods in which the sling application device maintainsthe opening or pocket and the methods in which the sling applicationdevice creates the opening or pocket are described below.

[0312] Each of the above described embodiments of the sling applicationdevice can be used according to the method described below and shown inFIGS. 54-65.

[0313] After inserting an obturator 1110 into the lumen 711 of the firstshaft such that the generally rigid tip 1118 extends from the distal endof the first shaft, the first shaft 716 is inserted percutaneously. Forexample, the first shaft 716 may be inserted into a first suprapubicincision 60, which is preferably approximately 1 to 1.5 inches inlength, and is located above a pubic tubercle. The first shaft 716 isadvanced into the patient's body and guided along the back side of thepubic bone to the upper vaginal wall. Once the vaginal wall is tented,placement is visually realized and lateral placement can then beadjusted. As shown in FIG. 54, the sling application device is thenrotated 90° such that the distal end of the first shaft 716 is directedperpendicular to the urethra 64 facing the tissue 62 between the urethra64 and the upper vaginal wall 66, creating and/or maintaining an openingor pocket in the tissue between the urethra and the upper vaginal wall.With the embodiments shown in FIGS. 47 and 48, the sling applicationdevice will rotate 90° as the device passes along the back of the pubicbone.

[0314] After inserting an obturator 1110 into the lumen 713 of thesecond shaft such that the generally rigid tip 1118 extends from thedistal end of the second shaft 718, the second shaft 718 is insertedpercutaneously. For example, the second shaft may be inserted into asecond suprapubic incision 60, which is preferably approximately 1 to1.5 inches in length, and is located above a pubic tubercle. The secondshaft 718 is advanced into position as described above such that thedistal end of the second shaft 718 is perpendicular to the urethra 64facing the tissue 62 between the urethra 64 and the upper vaginal wall66, thereby creating and/or maintaining an opening in the tissue betweenthe urethra and the upper vaginal wall. As shown in FIG. 55, at thecompletion of this step, the distal ends of the first and second shafts716, 718 oppose each other in the tissue 62 between the urethra 64 andthe upper vaginal wall 66.

[0315] After the sling application device is in position, the obturators1110 are removed from the first and second shafts 716, 718 and the first712 and second 714 handles are locked together with the adjuster 720 atits most proximal point, as shown in FIG. 56. The adjuster 720 isadvanced towards the distal extreme of the guide 748, progressivelydecreasing the distance between the distal ends of the first and secondshafts 716, 718 as shown in FIGS. 57 and 58. During this process, thephysician may observe the inner wall surface of the urethra 64 with acystoscope to avoid pinching the urethra. The physician also observesthe upper vaginal wall 66 to avoid pinching. When the first and secondshafts 716, 718 have been properly positioned, no pinching is observedat either the inner wall of the urethra or the upper vaginal wall.Correct placement is confirmed through touch and by visualizing a bulgein the upper vaginal wall at the desired positions.

[0316] Once correct placement has been obtained, the adjuster 720 isadvanced to the distal extreme of the guide 748, compressing the tissue62 between the distal ends of the first and second shafts 716, 718, asshown in FIG. 58.

[0317] In the methods in which the sling application device 710 createsthe pocket or opening in the tissue between the urethra and the uppervaginal wall, the tissue cutter 1310 is then inserted into the secondshaft 718 as shown in FIG. 59. When the thumb button 1322 of the razorassembly 1314 is depressed, the razor 1312 extends out of the distal endof the second shaft 718 and cuts the tissue 62 disposed between thedistal ends of the first and second shafts 716, 718, creating acontinuous opening 11 or pocket sized to receive the sling. The thumbbutton 1322 of the razor assembly 1314 is then released, causing therazor 1312 to retract within the second shaft 718. The razor assembly1314 is then removed from the second shaft 718.

[0318] In both the methods in which the sling application devicemaintains the pocket or opening and the methods in which the slingapplication device creates the pocket or opening, a sling or a slingintroducer 1210 having a releasably engaged sling 1211 attached theretois inserted through the opening 727 of the second handle and into thelumen of the second shaft 718, as shown in FIG. 60. The proximal end ofthe sling 1211 extends beyond the proximal end of the sling introducer1210. Long and short slings suitable for use with the present inventionare disclosed in the copending U.S. Patent Application entitled“Stabilization Sling for Use in Minimally Invasive Pelvic Surgery”(VESITEC.023A), filed simultaneously herewith, and the identicallytitled U.S. Provisional Patent Application Serial No. 60/038,379, filedFeb. 13, 1997, the disclosures of which are incorporated herein byreference.

[0319] Preferably, a porous sling introducer 1210 is used and the poroussling introducer 1210 with the sling 1211 attached thereto is soaked ina wetting and/or antibiotic solution as described above prior toinsertion into the first shaft.

[0320] The elongate distal end 1212 of the sling introducer is advancedthrough the opening 727 in the second handle, into the lumen of thesecond shaft 718, into the lumen of first shaft 716, and out the opening725 in the first handle as shown in FIG. 61. While holding the proximalend of the sling 1211, the elongate distal end 1212 of the slingintroducer 1210 is pulled. The sling introducer 1210 is advanced untilit exits the opening in the first handle 725, leaving the sling 1211within the first and second shafts 716, 718, as shown in FIG. 62.Following this step, the sling 1211 is located within the first 716 andsecond 718 shafts and extends out of the proximal ends of the openings725,727 in the first and second handles. As shown in FIG. 63, the end ofthe sling 1211 extending out of the proximal end of the opening in thefirst handle is grasped and the second shaft 718 is removed from thepatient's body, leaving the sling 1212 in the opening 11 in the tissuewhich was formerly occupied by the second shaft.

[0321] As shown in FIG. 64, the proximal end of the sling 1212 which hadformerly been inside the second shaft 718 is grasped, and the firstshaft 716 is removed from the patient's body. After this procedure, thesling 1211 passes through the continuous opening in the patient's bodytissue created by the above procedure, as shown in FIG. 65.

[0322] The sling 1212 may then be secured to a structure, such as thepubic bone by anchoring, stapling, riveting, or sewing to suspend orstabilize the bladder neck or create a platform to stabilize theurethral floor using approaches such as those disclosed in the copendingU.S. Patent Application entitled “Stabilization Sling for Use inMinimally Invasive Pelvic Surgery” (VESITEC.023A), filed simultaneouslyherewith, the identically titled U.S. Provisional Patent ApplicationSerial No. 60/038,379, filed Feb. 13, 1997, and U.S. Pat. No. 5,611,515,issued Mar. 18, 1997 to Benderev et al., the disclosures of which areincorporated herein by reference. Tension on the sling may be adjustedusing procedures such as those disclosed in the U.S. Pat. No. 5,611,515,issued Mar. 18, 1997 to Benderev et al., the disclosure of which isincorporated herein by reference, to support the bladder neck orstabilize the urethral floor, thereby maintaining or improving urinarycontinence.

Detachable Member Sling Application Device and Retrieval Device

[0323] Another aspect of the present invention relates to a detachablemember sling application device resembling the guide member placementdevice discussed above.

[0324] In general, the detachable member sling application devicecomprises a housing with an introduction shaft having a lumen extendingtherethrough connected to the housing. A detachable member is located onthe distal end of the introduction shaft, the detachable member beingconnected to at least one of the sutures attached to the sling. Thelumen in the shaft of the detachable member sling application device iscapable of receiving a sling therein. Preferably, the sling is in anaccordion like configuration when inside the lumen. The accordion likeconfiguration may consist of random folds.

[0325] Optionally, the detachable member sling application device mayfurther comprise an axially movable needle located inside the lumen ofthe introduction shaft. The needle, which comprises a needle shaft and asharpened point, is extendable from the introduction shaft.

[0326] As illustrated in FIGS. 66-81, the shaft bends toward its distalend in the same manner as discussed above with regard to the guidemember placement device.

[0327] A detachable member sling application device 1410 according tothe present invention is depicted in FIGS. 66-79. The detachable membersling application device comprises a housing 1412 and a shaft 1414 witha lumen 1416 extending therethrough. The shaft 1414 has an engagingmember 1411 near its distal tip for engaging a detachable member.Preferably, the engaging member 1411 comprises an annular ring on theouter surface of the shaft.

[0328] An axially movable inner shaft 1440 is located inside the shaft1414 and is extendable therefrom and retractable therein. The axiallymovable inner shaft 1440 has a lumen extending therethrough. Movement ofthe axially movable inner shaft 1440 is controlled by an actuator 1442which pivotally engages the housing 1412. Pivoting the actuator 1442distally causes the axially movable inner shaft to move distally.

[0329] An axially movable plunger 1444 is located inside the axiallymovable inner shaft 1440 and is extendable therefrom and retractabletherein. Movement of the axially movable plunger 1444 is controlled by abutton 1446 which slidably engages the housing 1412. The button 1446 ismovable between a first proximal position, a second intermediateposition, and a third distal position. When the button .1446 is in firstproximal position, sharpened point 1425 of the axially movable needle1422 is retracted in the detachable member.

[0330] An axially movable needle 1422 having a shaft 1423 and asharpened point 1425 at its distal end passes through an aperture in adeployment member 1448 which is located inside a detachable member 1424located at the distal end of the shaft 1414. A spring 1413 is disposedbetween the deployment member 1448 and the detachable member 1424. Theengaging member 1411 on the distal end of the shaft 1414 releasablyengages the detachable member 1424. Preferably, the detachable membercomprises a cup.

[0331] The detachable member 1424 has an engaging surface 1426 whichengages the distal end of the shaft and a connecting member 1450. Theconnecting member 1450 is connected to at least one suture 1428 attachedto a sling 1418 located in the lumen of the shaft 1414. Preferably, thesling 1418 is in an accordion like configuration inside the shaft 1414to reduce the amount of space it occupies.

[0332] When the button 1446 is in the intermediate position, thesharpened point 1425 of the axially movable needle 1422 is extended fromthe detachable member 1424 so as to permit the tissue to be easilypunctured while the device is advanced. When the button 1446 is in thedistal position, the axially movable needle 1422 is maximally extendedfrom the detachable member 1424 such that the shaft 1423 protrudes fromthe detachable member 1424 to permit extension through the hiatal areainto the vagina for ease of grasping and securing.

[0333] Another aspect of the present invention is a retrieval device forintroducing a sling into an opening or pocket in a body tissue. Oneembodiment of the retrieval device is illustrated in FIG. 67. Theretrieval device 2010 comprises a handle 2012 attached to a shaft 2014having an engaging member 2016 near its distal end.

[0334] The handle 2012 of the retrieval device may have a variety ofconfigurations which may vary depending on anatomical considerations andthe type of procedure being performed. For example, the handle may havea similar configuration as that of the detachable member slingapplication device shown in FIG. 66.

[0335] Similarly, the shaft 2014 of the retrieval device may have thesame configuration as the shaft 1414 of the detachable member slingapplication device 1410 shown in FIG. 66. Preferably, the engagingmember 2016 comprises an annular ring on the outer surface of the shaft2014.

[0336] In one embodiment, the retrieval device 2010 may be a modifieddetachable member sling application device 1410 having a hollow or solidshaft and lacking the actuator 1442, the button 1446, the detachablemember 1424, the sling 1418, and the mechanism inside the shaft fordeploying the detachable member.

[0337] The distal end of 2018 the shaft 2014 of the retrieval device hasan engaging member 2016 adapted to engage the detachable member 1424.Preferably, the engaging member 2016 comprises an annular ring on theouter surface of the shaft. The shaft 2014 of the retrieval device maybe solid or may have a hollow interior.

[0338] Although the detachable member sling application device 1410 andthe retrieval device 2010 described above and depicted in FIGS. 66 and67 may be used in a variety of procedures, a representative procedurefor using the device to apply a sling beneath the female urethra isdescribed below and depicted in FIGS. 68-81.

[0339] The first step of the procedure involves creating an opening orpocket 11 in the tissue 62 between the urethra 64 and the upper vaginalwall 66 into which the sling 1418 can be introduced. The opening orpocket 11 may be created in a variety of ways, including those describedherein and in the copending U.S. Patent Application No. entitled“Stabilization Sling for Use in Minimally Invasive PelvicSurgery”(VESITEC.023A) filed simultaneously herewith, and theidentically titled U.S. Provisional Patent Application Serial No.60/038,379, filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference.

[0340] A preferred method of creating the pocket involveshydrodissection. As shown in FIG. 68, a syringe 1430 filled with salineis inserted through the vaginal wall 66 into the tissue 62 between theurethra and the upper vaginal wall. A bolus of saline is dispensed intothe tissue, creating an opening or pocket 11 therein as shown in FIG.68. Preferably, the bolus comprises about 4 cc of saline. The shaft 1414of the detachable member sling application device is insertedpercutaneously. For example, the shaft 1414 may be insertedpercutaneously through a first suprapubic incision 61. The shaft 1414 ofthe detachable member sling application device 1410 is inserted therein.The shaft 1414 of the detachable member sling application device 1410 isadvanced through the patient's body tissue along the back side of thepubic bone to the opening or pocket 11 created in the tissue 62 betweenthe urethra 64 and the upper vaginal wall 66, as shown in FIG. 69.During advancement of the shaft 1414, the button 1446 may be advancedfrom the most proximal position, in which the sharpened point 1425 ofthe needle is within the detachable member 1424, to the intermediateposition, in which the sharpened point 1425 of the needle extends fromthe detachable member. In particular, the sharpened point 1425 may beextended to dissect through muscle groups.

[0341] The distal end of the shaft 1414 is advanced percutaneously orlaparoscopically to the bottom of the pocket or opening 11 and thebutton 1446 is advanced to the most distal position, in which the needle1422 is maximally extended and the sharpened point 1425 passes throughthe upper vaginal wall 66 as shown in FIG. 70. The needle 1422 issecured on the vaginal side with a device such as a hemostat 1432 asshown in FIG. 71.

[0342] As shown in FIG. 72, the detachable member 1424 is then detachedfrom the distal end of the shaft 1414 by pivoting the actuator 1442distally, thereby causing the inner shaft 1440 to move distally suchthat it contacts the deployment member 1448 and pushes the detachablemember 1424 off the distal end of the shaft 1414.

[0343] As illustrated in FIG. 73, the needle 1422 is toggled within thepocket or opening 11 such that the engaging surface 1426 of thedetachable member will be accessible to the engaging member 2016 of aretrieval device 2010. Preferably, the needle is toggled from about 30°to about 150°. More preferably the needle is toggled from about 60° toabout 120°. In a highly preferred embodiment, the needle is toggledabout 90°.

[0344] As will be appreciated by those skilled in the art, other methodsof positioning the detachable member for engaging the engaging member ofa retrieval device may be used with embodiments of the detachable membersling application device which do not have the axially movable needle.

[0345] The shaft 2014 of a retrieval device is advanced percutaneouslyor laparoscopically into the opening or pocket 11 as shown in FIG. 74.For example, the shaft may be advanced into the opening or pocketthrough a second suprapubic incision 60.

[0346] The distal end of the shaft 2014 of the retrieval device isinserted into the detachable member 1424 and the engaging member 2016engages the engaging surface 1426 of the detachable member 1424 as shownin FIG. 75. As shown in FIG. 76, the needle 1422 protruding through thevaginal wall 66 is then pulled out of the deployment member 1448 andremoved from the vagina so as not to draw bacteria back into the pelvicarea.

[0347] As the shaft 2014 of the retrieval device is withdrawn from thepocket or opening 11, the connecting member 1450 on the detachablemember 1424 pulls the sutures 1428 connected to the sling 1418 out ofthe shaft 1414 of the detachable member sling application device 1410,as illustrated in FIG. 77. As the shaft 2014 of the retrieval device iswithdrawn further from the pocket or opening 11, the sling 1418 and thesutures 1428 connected thereto are pulled out of the shaft 1414 of thedetachable member sling application device 1410, as illustrated in FIG.78.

[0348] The shaft 1414 of the detachable member sling application device1410 and the shaft 2014 of the retrieval device 2010 are withdrawn fromthe patient's body as shown in FIG. 79. The sling 1418 is thereby leftin the opening or pocket 11 between the urethra 64 and the upper vaginalwall 66 such that the sutures 1428 extend from the first and secondsuprapubic incisions 60, 61 patient's body, as shown in FIG. 80.

[0349] Preferably, the sutures 1428 or integral attachment membersattached to the sling 1418 have markings 1436 thereon for ensuring thatthe sling 1418 is properly centered beneath the urethra in the openingor pocket 11. The markings 1436 on the sutures or integral attachmentmembers are equidistant from the center 1438 of the sling. Followingplacement of the sling 1418 in the opening or pocket 11, the physiciancrosses the sutures 1428 as shown in FIG. 81. When the markings 1436 onthe sutures 1428 or integral attachment members are positioned along aline extending transversely to the patient's abdomen, as shown in FIG.81, the sling 1418 is properly centered in the pocket or opening 11.

[0350] The sling can then be attached to a bone anchor or otherstructures, and tensioned to support the bladder neck or stabilize theurethral floor, thereby maintaining or improving urinary continence,using approaches such as those described in the copending U.S. PatentApplication entitled “Stabilization Sling for Use in Minimally InvasivePelvic Surgery” (VESITEC.023A), filed simultaneously herewith, theidentically titled U.S. Provisional Patent Application Serial No.60/038,379, filed Feb. 13, 1997 and U.S. Pat. No. 5,611,515, issued Mar.18, 1997 to Benderev et al., the disclosures of which are incorporatedherein by reference.

Tissue Expander, Grasping Device, and Balloon Catheters

[0351] A further aspect of the invention relates to hiatal techniquesfor creating an opening or pocket in the tissue between the urethra andthe upper vaginal wall and devices for use in the hiatal techniques. Thehiatal methods can be practiced without the necessity for a vaginalincision, thus minimizing the risk of infection from the procedure.

[0352] As will be described in greater detail below, in the hiatalapproach a lumen is created in the hiatal tissue between the urethra andthe upper vaginal wall. The lumen is then expanded to create an openingor pocket of a size sufficient to accept a sling. The opening or pocketis then held open with the tissue expander while a first suture orflexible guide member is percutaneously advanced into the opening orpocket. The guide member may be a suture, guidewire, or other structuresuitable for guiding a sling to a desired location. The first suture orflexible guide member is grasped with a grasping device and withdrawnthrough the lumen and out of the body. The process is repeated with asecond suture or flexible guide member on the opposite side of theurethra. The two sutures or flexible guide members are then tiedtogether to create a guide for delivering a sling into the pocket. Theknotted section of the suture or guide member is then translocatedoutside of the body so that the progress of the sling along the sutureor guide member is unimpeded.

[0353] Alternatively, the sling may be attached to the sutures extendingoutside of the body, rolled or restuffed, and drawn into the bodythrough the lumen by pulling on the sutures.

[0354] As discussed above, after creation of the lumen in the hiataltissue, the lumen is expanded to create a pocket or opening. One aspectof the present invention relates to balloon catheters for expanding thelumen and creating the pocket or opening. The balloon cathetersgenerally comprise an outer tube having a lumen extending therethroughand at least one expandable balloon inside the outer tube. Theexpandable balloon has a blunt dissection tip at its distal end havingsufficient rigidity to allow it to create an opening in a body tissuewhen contacting the tissue.

[0355] One embodiment of a balloon catheter 536 suitable for use in thehiatal approach was described above and is shown in FIG. 26.

[0356] In the embodiment shown in FIG. 26, there is a single expandableballoon 540. In an alternative embodiment of the balloon catheter, thereis more than one balloon. This embodiment permits the creation of anopening or pocket wide enough to accommodate the sling using balloonshaving a smaller diameter than would a single balloon capable ofcreating a pocket of that width. In this way, tearing of tissue aboveand below the pocket is minimized.

[0357]FIG. 82 shows a preferred embodiment 1536 in which there are twoexpandable balloons 1540 and 1541 in the lumen of the outer tube 1538which are joined at their distal ends. Preferably, the expandableballoons are joined at their distal ends by a blunt dissection tip 1546.The blunt dissector tip may comprise a plastic or metal cap.Alternatively, the ends of the two balloons may be potted together. Inthe embodiment of FIG. 82, the two balloons have a common inflationtube. However, those skilled in the art will appreciate that theballoons may also have separate inflation tubes.

[0358]FIG. 83 shows the embodiment of FIG. 82 in which the balloons1540, 1541 have been inflated. As illustrated in FIG. 83, the balloons1540, 1541 have a generally cylindrical configuration when inflated. Inthis embodiment, each balloon 1540, 1541 may be from about 2 cm to about3 cm in length and has a diameter when expanded of from about 1 cm toabout 2.5 cm. In a preferred embodiment, each balloon 1540, 1541 is fromabout 2 cm to about 3 cm in length and has a diameter when expanded offrom about 1.5 cm to about 2 cm. More preferably, each balloon is about2.75 cm in length and 2.5 cm in diameter when expanded.

[0359] Some physicians prefer procedures which take place beneath thepelvic floor so as to avoid any unnecessary disruption of muscle, theslings are preferably about 1.5 cm to about 6 cm in length and about 2cm in width. More preferably, the slings used in such procedures are 2.5cm to 4 cm in length, although longer slings may be more manageable forgeneral surgeons since they allow for slippage off center duringplacement.

[0360] Other physicians prefer procedures which break through the pelvicfloor and produce scarring which may reinforce the area. In suchprocedures, the slings may be as long as 20-25 cm. These long slingsminimize the length of attaching suture and permit more tissue ingrowthwhile providing security against suture breakage. Preferably, the slingsused in such procedures are about 2 cm wide.

[0361] Those skilled in the art will appreciate that the slingdimensions can be varied as appropriate. In any case, however, it ispreferred that the balloon on the balloon catheter is appropriatelysized to create a pocket or opening capable of accommodating the sling.

[0362] Alternatively, a balloon catheter 1636 having a flat profileballoon 1640 may be used to create the lumen. The flat profile balloon1640 is capable of forming a flat pocket sized to receive a sling whileavoiding the unnecessary dilation or tearing of tissue above and belowthe sling pocket which may occur if a cylindrical balloon was used tocreate the pocket. Preferably, the flat profile balloon 1640 has asquare or rectangular shape when inflated. However, those skilled in theart will appreciate that other shapes are compatible with the presentinvention and that the shape may be readily modified to be compatiblewith the particular device or procedure used.

[0363] The flat profile balloons 1640 are preferably made of two sheetsof noncompliant material such as mylar, polyethylene, or PET.Alternatively, the balloons may be made by blow molding.

[0364] A flat profile balloon 1640 according to the present invention isshown in FIG. 84. As illustrated, the balloon 1640 has a series ofinternal non-expansive ribs 1650 which serve to maintain a shallowprofile after expansion, direct the flow of air to promote evenunrolling during expansion, reduce buckling in critical areas afterexpansion, and provide a conduit structure which delivers a consistentexpansion of tissue into the desired shape. The internal structure ofthe catheter and balloon 1640 are further illustrated in the crosssectional views of FIGS. 85 and 86.

[0365] As illustrated in FIG. 84, the balloon 1640 is located at thedistal end of a generally rigid inflation tube 1642 which extendsthrough the interior of the balloon 1640. The inflation tube 1642provides a generally rigid support structure during advancement andplacement of the balloon 1640 in the body tissue. Preferably, theinflation tube 1642 has a series of fill holes 1658 in the interior ofthe balloon 1640 which promote uniform inflation of the balloon.However, those skilled in the art will appreciate that a single fillhole may also be used.

[0366] In one embodiment, shown in FIG. 85, the inflation tube 1642 hastwo lumens in its interior. One lumen, the guide lumen 1652, is adaptedto receive a guide member, while the other lumen, the inflation lumen1654, is for inflation of the balloon and is in fluid communication withthe interior of the balloon. In an alternative embodiment, the catheterhas a single inflation lumen.

[0367] Those skilled in the art will appreciate that the catheter may beprovided with more than two lumens to accommodate other instrumentsnecessary to perform the surgical procedure.

[0368] The inflation tube has a luer tip 1656 at its proximal end whichis adapted to engage a syringe filled with saline or sterile water. Whenthe plunger of the syringe is depressed, fluid is force through theinflation lumen 1642 and out of the fill holes into the interior of theballoon, causing the balloon 1640 to inflate. When the plunger of thesyringe is retracted, a vacuum is created, drawing the fluid out of theballoon 1640 and causing the balloon to deflate 1640.

[0369] In a preferred embodiment, the balloon 1640 is rolled on theexterior surface of the inflation tube 1642 to reduce its entry profile.

[0370] Those skilled in the art will appreciate that the above describedballoon catheters 536, 1536, 1636 can be used to dilate body tissues incontexts other than the hiatal procedures discussed below. For example,the balloon catheters 536, 1536, 1636 may be utilized in the tissuedissector/dilator 510 described above, or may be used to create apre-formed opening for receiving the guide member placement devices 10,1910, the sling application devices 710, 810, 910, 1010, or thedetachable member sling application devices 1410 described above.

[0371] Additionally, the balloon catheters 536, 1536, 1636 of thepresent invention can also be used to create the opening or pocket inthe tissue between the urethra and the upper vaginal wall intransvaginal incontinence treatments. In such transvaginal proceduresthe balloon catheter is inserted through the upper vaginal wall into thearea in which the opening or pocket is to be made. The balloon is thenexpanded, creating the opening or pocket for receiving a sling. In someinstances, the physician may use the balloon catheters in conjunctionwith transvaginal bone anchor implantation devices such as thosedisclosed in the copending U.S. patent application Ser. No. 08/744,439entitled “Transvaginal Anchor Implantation Device”, filed Nov. 8, 1996,the disclosure of which is incorporated herein by reference. However,use of the balloon catheters in conjunction with transvaginal boneanchor implantation devices may impact the expense of such procedures.

[0372] The balloon catheters described above and depicted in FIGS. 2Band 82-86 may be introduced into the body in a number of ways. In onemethod a needle or guide member is inserted into the hiatal tissue tothe desired location. The needle or guide member is inserted into theguide lumen of the catheter. The catheter is advanced along the guidemember or needle to the desired location. A syringe filled with salineor sterile water is attached to the luer tip at the end of the catheterand the plunger of the syringe is depressed, ejecting the fluid from thesyringe and causing the balloon to inflate. The inflated balloon dilatesor tears the tissue thereby creating a shallow opening or pocket adaptedto receive a sling.

[0373] In an alternate procedure, a hollow needle or trocar isintroduced into the body tissue and advanced to the desired location. Aballoon catheter, which may have a single inflation lumen, is passedthrough the lumen of the needle or trocar and advanced to the end. Theneedle or trocar is partially withdrawn from the patient's body toexpose the balloon. The balloon is inflated and deflated as describedabove to create an opening or pocket adapted to receive a sling.

[0374] Further aspects of the present invention relate to tissueexpanders 1710 for expanding an opening or pocket in a body tissue andgrasping devices 1810 for grasping a suture advanced into the opening orpocket.

[0375] In general, the tissue expander comprises a tube with a lumenextending therethrough, an expandable and collapsible member attached tothe tube for insertion into the opening within the body tissue andexpansion thereof, and an expansion and collapse control incommunication with the expandable and collapsible member for moving theexpandable and collapsible member between a first position in which itis collapsed and a second position in which it is expanded.

[0376] One embodiment of a tissue expander 1710 according to the presentinvention is shown in FIG. 87. The tissue expander comprises a tube 1712with a lumen 1714 extending therethrough. Preferably, the lumen 1714 ofthe tube 1712 is of sufficient diameter to permit a visualizer, such asa fiberoptic scope, and a grasping device to be simultaneously housedtherein.

[0377] An expansion basket 1716 is attached to the tube 1712.Preferably, the expansion basket 1716 comprises a plurality of wires1718 joined at their distal ends by a tip 1720 which is connected to apull wire 1722. The expansion basket 1716 is movable between a firstposition in which it is collapsed (indicated with solid lines) and asecond position in which it is expanded (indicated with dashed lines) asshown in FIG. 87. When the pull wire 1722 is pulled towards the proximalend of the device, the expansion basket 1716 moves to the expandedposition. When the pull wire 1722 is released, the expansion basket 1716collapses.

[0378] The expansion basket 1716 may be fabricated from a variety ofmaterials such as stainless steel or Nitinol. Preferably, the expansionbasket 1716 is made of stainless steel.

[0379] The expansion basket 1716 may expand the tissue from about 0.25inch to about 1.5 inches. Preferably, the expansion basket 1716 expandsthe tissue from about 0.5 inch to about 1.25 inches. In a highlypreferred embodiment, the expansion basket 1716 expands the tissue aboutone inch.

[0380] In an alternative embodiment of the tissue expander, aself-expanding net or a self-expanding mesh tube may be used in place ofthe expansion basket.

[0381] A further aspect of the present invention relates to a graspingdevice which is adapted to fit inside the lumen of the tube of thetissue expander described above. When inserted into the lumen of thetube of the tissue expander, the grasping device is axially movable andextendable from and retractable in the lumen of the tube. Generally, thegrasping member comprises a catheter with a grasper on its distal end.

[0382] A grasping device 1810 according to the present invention isshown in FIG. 88. The grasping device 1810 comprises an elongate member1812 and self-expanding grasping basket 1814 attached to the distal endof the elongate member 1812.

[0383] Preferably, the grasping device 1810 is adapted to fit inside thetube 1712 of the tissue expander 1710. When the self-expanding graspingbasket 1814 is inside the lumen of the tube 1712 of the tissue expander1710, it is held in a collapsed configuration by the tube 1712. However,when the self-expanding grasping basket 1814 is extended outside thetube 1712, it expands. Preferably, in its expanded state, theself-expanding grasping basket 1814 on the grasping device 1810 fitsinside the expansion basket 1716 of the tissue expander 1710. When thegrasping device 1810 is retracted back into the lumen 1714 of the tube1712 it collapses.

[0384] The above grasping devices 1810 and tissue expanders 1710 can beused in a wide variety of surgical procedures in which it is necessaryto expand an opening in a body tissue and grasp a suture which has beenadvanced into the expanded opening. For illustrative purposes, the useof the above devices in a hiatal bladder neck stabilization procedure isdescribed below.

[0385]FIG. 89 shows the urethra 64, the vagina 1836, the hiatal tissue62 between the urethra and the upper vaginal wall, and a target site1816 for insertion of a device for creating a lumen 1818 in the hiataltissue. In the hiatal bladder neck stabilization procedure disclosedherein, the urethra 64 is straightened prior to creation of the lumen1818 in the hiatal tissue.

[0386] As shown in FIG. 90, the urethra 64 can be straightened with aFoley catheter 1820 inside a large bore tube 1822. The large bore tube1822 fits securely over the Foley catheter and extends out of theurethra. Preferably, the large bore tube is sufficiently firm torigidify the Foley catheter.

[0387] Preferably, the large bore tube 1822 comprises a metal shaft. Ina preferred embodiment the metal shaft includes a means to measure thelength of the urethra from the bladder neck to the proximal end. In someembodiments, the large bore tube 1822 has guide means thereon whichallow the needle 1830 or other dissecting device for dissecting thehiatal tissue, such as a cutter knife, to be guided to the desired site.Such devices are described in the copending U.S. Patent Applicationentitled “Method and Apparatus for Minimally Invasive Pelvic Surgery,”(VESITEC.028A) filed simultaneously herewith, and the identically titledU.S. Provisional Patent Application Serial No. 60/038,380, filed Feb.13, 1997, the disclosures of which are incorporated herein by reference.

[0388] As shown in FIG. 90, the Foley catheter 1820 is inserted into theurethra 64 and advanced to the bladder neck 1826. When the balloon 1828of the Foley catheter is inside the bladder neck 1826, it is inflated.Alternatively, the urethra 64 may be straightened with a urethroscope orby other methods familiar to those skilled in the art.

[0389] As shown in FIG. 91, a large bore needle 1830 is inserted intothe hiatal tissue 62 between the urethra 64 and the upper vaginal wall66 at the target site 1816 indicated in FIG. 89. An appropriately sizedneedle may be selected by measuring the distance between the balloon1828 of the Foley catheter 1820, which is positioned at the bladder neck1826, and the external urethra. The needle should be slightly shorterthan the measured length. For example, the needle may be approximately0.25 inch less than the measured length.

[0390] The needle 1830 may be guided by eye or may be mechanicallyguided to penetrate the hiatal tissue parallel to the withoutpenetrating the upper vaginal wall. The needle is advanced parallel tothe urethra 64 below the midline of the urethra As shown in FIG. 92, theneedle 1830 is partially retracted and the lumen 1818 in the hiataltissue 62 which was created by the needle 1830 provides an accesschannel for the devices discussed above.

[0391] Alternatively, a bi-polar RF cutter may be used to dissect anopening in the hiatal tissue. The bi-polar cutting device comprises apair of wires, one flexible and one rigid, for cutting a slot from theproximal portion of the hiatus to the bladder neck having a widthadapted for receiving a sling therein. Preferably, the bi-polar cuttingdevices uses 80 Watts of power to cut and coagulate the tissue. In thisembodiment, the large bore tube 1822 in which the Foley catheter isplaced has a series of thermistors and associated connectors whichprovide temperature feedback for use in conjunction with a bi-polar RFcutter device. Such devices are described in the copending U.S. PatentApplication entitled “Method and Apparatus for Minimally Invasive PelvicSurgery” (VESITEC.028A) filed simultaneously herewith, and theidentically titled U.S. Provisional Patent Application Serial No.60/038,380, filed Feb. 13, 1997, the disclosures of which areincorporated herein by reference.

[0392] A balloon catheter 536 is inserted into the bore of the needle1830 and advanced beyond the tip of the needle 1830 into the lumen 1832in the hiatus as shown in FIG. 93. Although FIG. 93 shows the ballooncatheter 536 depicted in FIG. 26 being used, the balloon catheters 1536and 1636 depicted in FIGS. 82-86 may also be used.

[0393] As shown in FIG. 94, the balloon 540 is then inflated with salineor sterile water, dilating the hiatal tissue 62 around the lumen 1818created by the large bore needle 1830. The balloon 540 is then deflatedand the balloon catheter 536 is withdrawn from the patient's body.

[0394] The tissue expander 1710 is inserted into the large bore of theneedle 1830 and advanced beyond the tip of the needle into the lumen1818 in the hiatal tissue 62, as shown in FIG. 95. The pull wire 1722 isthen pulled towards the proximal end of the tissue expander 1710,causing the expansion basket 1716 to adopt the expanded configurationand thereby expanding the lumen 1818 in the hiatal tissue as shown inFIG. 96.

[0395] A fiberoptic scope 1832 is inserted into the tube 1712 of thetissue expander 1710 and is extended into the interior of the expansionbasket 1716.

[0396] A guide member placement device 10 such as that described aboveis used to advance a suture 1834 or guide member from a suprapubicincision, along the back side of the pubic bone toward the upper vaginalwall. The suture 1834 or guide member is extended into the expansionbasket 1716 of the tissue expander 1710 as shown in FIG. 97. The fiberoptic scope 1832 permits the physician to visualize the position of thesuture 1834 or guide member in order to determine when the suture 1834or guide member is within the expansion basket 1716.

[0397] A grasping device 1810 is inserted into the lumen 1714 of thetube 1712 of the tissue expander 1710. The self-expanding graspingbasket 1814 of the grasping device is extended from the tube 1712,causing the self-expanding basket 1814 to expand, as shown in FIG. 97.The suture 1834 or guide member 68 is positioned inside theself-expanding basket 1814 and the self-expanding basket 1814 is pulledback into the lumen 1714 of the tube 1712, causing the self-expandingbasket 1834 to collapse and grasp the suture 1834 or guide member, asshown in FIG. 98. As shown in FIG. 99, the self expanding basket 1814 iswithdrawn through the tube 1712, drawing the suture toward the outsideof the patient's body. The grasping device 1810 is removed from the tube1712, pulling the suture 1834 outside the patient's body.

[0398] A second suture is advanced along the back side of the pubic bonetoward the upper vaginal wall with a guide member placement device asdescribed above. The second suture is positioned on the opposite side ofthe urethra from the first suture and is advanced into the expansionbasket, grasped with the grasping basket, and drown outside thepatient's body as described above. Following this procedure, a secondsuture or guide member extends from the patient's body.

[0399] The large bore needle 1830 and tissue expander 1710 are thenremoved from the patient's body. The ends of the two sutures are knottedtogether and the ends of the knotted suture extending from thesuprapubic incisions are pulled to draw the knotted suture back into thebody. The knot is advanced out of one of the suprapubic incisionsproviding an uninterrupted suture or guide member extending between thesuprapubic incisions around the urethra. The suture provides a guidepath from the suprapubic incisions around the urethra which may be usedto introduce a sling using a sling introduction catheter as describedabove.

[0400] In an alternative embodiment, the large bore needle 1830 is leftin place. A sling is secured to the sutures outside the body, rolled orrestuffed, and then drawn through the bore of the needle and into theopening or pocket in the body tissue by pulling on the ends of thesutures extending from the suprapubic incisions.

[0401] The tension on the sling may be adjusted as described above. Boneanchors or other means may be used to secure the sutures as discussedabove to support the bladder neck or stabilize the urethral floor,thereby maintaining or improving urinary continence.

[0402] Although this invention has been described in terms of certainpreferred embodiments, other embodiments which will be apparent to thoseof ordinary skill in the art in view of the disclosure herein are alsowithin the scope of this invention. Accordingly, the scope of theinvention is intended to be defined only by reference to the appendedclaims. In addition, for clarity, letter references are used in some ofthe claims. These letter references, however, are not meant to imply anyparticular order for performing the method steps.

1-156. (Cancelled).
 157. A method for treating female urinaryincontinence comprising, inserting a shaft having a curved portionpercutaneously into a body and through a vaginal wall of a patient;associating a sling assembly end with an end of the shaft subsequent tothe shaft extending through the vaginal wall; and withdrawing the shaftto place at least a portion of the sling assembly under a urethra of thepatient.
 158. The method of claim 157, wherein the sling assemblycomprises an element for receiving a distal end of the shaft.
 159. Themethod of claim 157 comprising inserting the shaft via an abdomen of thepatient.
 160. The method of claim 157, wherein the shaft comprises achannel for receiving the sling assembly end.
 161. The method of claim160 comprising locking the sling assembly end in the channel.
 162. Themethod of claim 160 comprising unlocking the sling assembly end from thechannel subsequent to withdrawing the shaft.
 163. The method of claim157 comprising disassociating the sling assembly end from the shaft endsubsequent to withdrawing the shaft.
 164. The method of claim 157,wherein the sling assembly comprises a sling.
 165. The method of claim157, wherein the sling assembly comprises a sling and a pouch enclosingat least partially the sling.
 166. The method of claim 165 comprisingremoving the sling from a pouch subsequent to sling assembly placement.167. The method of claim 157, wherein the end of the shaft is a distalend.
 168. A method for treating female urinary incontinence comprising,inserting a shaft having a curved portion percutaneously into a body andthrough a vaginal wall of a patient; associating a sling assembly end toan end of the shaft subsequent to the shaft extending through thevaginal wall; and withdrawing the shaft to pull at least a portion ofthe sling assembly through the vaginal wall to place at least a portionof the sling assembly under a urethra of the patient.
 169. The method ofclaim 168 comprising inserting the shaft via an abdomen of the patient.170. The method of claim 168 comprising disassociating the slingassembly end with shaft subsequent to withdrawing the shaft.
 171. Themethod of claim 168, wherein the sling assembly comprises a sling. 172.The method of claim 168, wherein the sling assembly comprises a slingand a pouch enclosing at least partially the sling.
 173. The method ofclaim 172 comprising removing the sling from the pouch.
 174. A methodfor treating female urinary incontinence comprising, inserting first andsecond shafts, each having a curved portion, percutaneously into a bodyand through a vaginal wall of a patient; associating a first end of asling assembly with the first shaft; associating a second end of thesling assembly with the second shaft; and placing at least a portion ofthe sling assembly under a urethra of the patient.
 175. The method ofclaim 174, wherein the step of inserting comprises inserting the firstshaft and then inserting the second shaft.
 176. The method of claim 174comprising inserting at least one of the shafts via the abdomen. 177.The method of claim 174 comprising withdrawing at least one of the firstand second shafts to place at least a portion of the sling assemblyunder a urethra of the patient.
 178. The method of claim 174 comprisingdisassociating the first and second assembly ends from the shaftssubsequent to withdrawing the shafts from the body.
 179. The method ofclaim 174, wherein the sling assembly comprises a sling.
 180. The methodof claim 174, wherein the sling assembly comprises a sling and a pouchfor enclosing at least partially the sling.
 181. The method of claim 180comprising removing the sling from the pouch.
 182. A method for treatingfemale urinary incontinence comprising, inserting a shaft having acurved portion percutaneously into a body and through a vaginal wall ofa patient; associating a sling assembly with an end of the shaft; andwithdrawing the shaft to place at least a portion of the sling assemblyunder the urethra.
 183. The method of claim 182, wherein the associatingcomprises interfitting the sling assembly in a channel located at an endof the shaft.
 184. The method of claim 182, wherein the associatingcomprises releasably interfitting the sling assembly in a channellocated at an end of the shaft.
 185. The method of claim 182 comprisingdissociating the sling assembly from the shaft subsequent to withdrawingthe shaft from the body of the patient.
 186. The method of claim 182,wherein the sling assembly comprises a sling.
 187. The method of claim182, wherein the sling assembly comprises an elongated extension locatedat an end of the sling assembly.
 188. The method of claim 182, whereinthe sling assembly comprises an aperture located at an end of the slingassembly.
 189. The method of claim 182, wherein the sling assemblycomprises a sling and a pouch for enclosing at least partially thesling.
 190. The method of claim 189, wherein the pouch comprises anopening intermediate to first and second ends of the sling assembly.191. The method of claim 189, wherein the pouch is substantially flat.